FDA · Medical device recall

Stradis Healthcare… and 77 more products

Dec. 21, 2022 Class II

Date: Dec. 21, 2022
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: Stradis Medical, LLC dba Stradis Healthcare
Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Distribution pattern: US nationwide distribution, and Canada.

78 products in this recall

Stradis Healthcare…

Product: STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Quantity: 80 kits
Codes and lots: a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484
Recall started: Nov. 2, 2022
Device type: Sponge, Ophthalmic
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0481-2023

ACE Surgical Supply…

Product: ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Quantity: 10 kits
Codes and lots: UDI/DI (case) M75200338800, UDI/DI (kit)M75200338800, Serial/Lot Numbers: 22242490999
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0482-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Quantity: 25 units
Codes and lots: UDI/DI (case) M75220177RPSS1, UDI/DI (kit)M75220177RPSS0, Serial/Lot Numbers: 22263491083
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0483-2023

Basic Implant Pack…

Product: BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Quantity: 80 units
Codes and lots: UDI/DI (case) M75240310SBI1, UDI/DI (kit)M75240310SBI0, Serial/Lot Numbers: 22241489853
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0484-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
Quantity: 12 units
Codes and lots: UDI/DI (case) M75240450SMS1, UDI/DI (kit)M75240450SMS0, Serial/Lot Numbers: 22262490676
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0485-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Quantity: 18 units
Codes and lots: UDI/DI (case) M75240510TWS1, UDI/DI (kit)M75240510TWS0, Serial/Lot Numbers: 22236490637
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0486-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Quantity: 6 units
Codes and lots: UDI/DI (case) M75240551TMS1, UDI/DI (kit)M75240551TMS0, Serial/Lot Numbers: 22230489112
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0487-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Quantity: 20 units
Codes and lots: UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0488-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Quantity: 6 units
Codes and lots: UDI/DI (case) M75240649ECS1, UDI/DI (kit)M75240649ECS0, Serial/Lot Numbers: 22270491425
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0489-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Quantity: 18 units
Codes and lots: UDI/DI (case) M75240714IES1, UDI/DI (kit)M75240714IES0, Serial/Lot Numbers: 22229490633, 22229490633, 22229490633
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0490-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
Quantity: 6 units
Codes and lots: UDI/DI (case) M75240788SMS1, UDI/DI (kit)M75240788SMS0, Serial/Lot Numbers: 22234489435
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0491-2023

Surgical room…

Product: Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
Quantity: 180 units
Codes and lots: UDI/DI (case) M75240996WLS1, UDI/DI (kit)M75240996WLS0, Serial/Lot Numbers: 22230489371
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0492-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Quantity: 30 units
Codes and lots: UDI/DI (case) M75241015NSI1, UDI/DI (kit)M75241015NSI0, Serial/Lot Numbers: 22230491043
Recall started: Nov. 2, 2022
Device type: General Purpose Dental Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0493-2023

Surgical room…

Product: Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
Quantity: 162 units
Codes and lots: UDI/DI (case) M7524111UTI0, UDI/DI (kit)M7524111UTI0, Serial/Lot Numbers: 22229491074
Recall started: Nov. 2, 2022
Device type: Endodontic Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0494-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
Quantity: 20 units
Codes and lots: UDI/DI (case) M75241137TDS1, UDI/DI (kit)M75241137TDS0, Serial/Lot Numbers: 22230489097
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0495-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
Quantity: 12 units
Codes and lots: UDI/DI (case) M75241213ATCP1, UDI/DI (kit)M75241213ATCP0, Serial/Lot Numbers: 22262491452
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0496-2023

Surgical room…

Product: Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
Quantity: 20 units
Codes and lots: UDI/DI (case) M75241236SDSP1, UDI/DI (kit)M75241236SDSP0, Serial/Lot Numbers: 22235489632
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0497-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
Quantity: 100 units
Codes and lots: UDI/DI (case) M7525050101, UDI/DI (kit)M7525050100, Serial/Lot Numbers: 22269491064,
Recall started: Nov. 2, 2022
Device type: Applicator, Absorbent Tipped, Sterile
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0498-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
Quantity: 100 units
Codes and lots: UDI/DI (case) M7525150011, UDI/DI (kit)M7525150011, Serial/Lot Numbers: 22258491483
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0499-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
Quantity: 180 units
Codes and lots: UDI/DI (case) M7525250381, UDI/DI (kit)M7525250380, Serial/Lot Numbers: 22251491752,
Recall started: Nov. 2, 2022
Device type: Percutaneous Sheath Introducer Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0500-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
Quantity: 150 units
Codes and lots: UDI/DI (case) M7525250711, UDI/DI (kit)M7525250710, Serial/Lot Numbers: 22252491061
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0501-2023

Henry Schein…

Product: HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
Quantity: 10 units
Codes and lots: UDI/DI (case) H65857006111, UDI/DI (kit)M75257006110, Serial/Lot Numbers: 22257490683
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0502-2023

Henry Schein…

Product: HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
Quantity: 800 units
Codes and lots: UDI/DI (case) H65857014261, UDI/DI (kit)M75257014260, Serial/Lot Numbers: 22257490682
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0503-2023

Henry Schein…

Product: HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Quantity: 15 units
Codes and lots: UDI/DI (case) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 22230491082
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0504-2023

Henry Schein…

Product: HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Quantity: 20 units
Codes and lots: UDI/DI (case) M75257014821, UDI/DI (kit)M75257014820, Serial/Lot Numbers: 22235489736
Recall started: Nov. 2, 2022
Device type: Laparoscopic Cholecystectomy Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0505-2023

Henry Schein…

Product: HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
Quantity: 35 units
Codes and lots: UDI/DI (case) H65857015081, UDI/DI (kit)M75257015080, Serial/Lot Numbers: 22252490204
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0506-2023

Henry Schein…

Product: HENRY SCHEIN, Basin Pack, Item No.570-1692
Quantity: 30 units
Codes and lots: UDI/DI (case) H65857016921, UDI/DI (kit)M75257016920, Serial/Lot Numbers: 22257490755
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0507-2023

Henry Schein…

Product: HENRY SCHEIN, Basin Set, Item No.570-1803
Quantity: 96 units
Codes and lots: UDI/DI (case) H65857018031, UDI/DI (kit)M75257018030, Serial/Lot Numbers: 22258490734
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0508-2023

Henry Schein…

Product: HENRY SCHEIN, BREAST PACK, Item No.570-2397
Quantity: 8 units
Codes and lots: UDI/DI (case) H65857023971, UDI/DI (kit)M75257023970, Serial/Lot Numbers: 22235489451
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0509-2023

Henry Schein…

Product: HENRY SCHEIN, GYN PACK, Item No.570-2625
Quantity: 20 units
Codes and lots: UDI/DI (case) H65857026251, UDI/DI (kit)M75257026250, Serial/Lot Numbers: 22230491067
Recall started: Nov. 2, 2022
Device type: Vaginal Examination Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0510-2023

Henry Schein…

Product: HENRY SCHEIN, ENT PACK, Item No.570-2718
Quantity: 104 units
Codes and lots: UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582, 22256491864
Recall started: Nov. 2, 2022
Device type: Oral Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0511-2023

Henry Schein…

Product: HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
Quantity: 24 units
Codes and lots: UDI/DI (case) H65857027181, UDI/DI (kit)M75257027180, Serial/Lot Numbers: 22242489582
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0512-2023

Henry Schein…

Product: HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
Quantity: 18 units
Codes and lots: UDI/DI (case) H65857027381, UDI/DI (kit)M75257027380, Serial/Lot Numbers: 22257490591
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0513-2023

Henry Schein…

Product: HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
Quantity: 12 units
Codes and lots: UDI/DI (case) H65857027421, UDI/DI (kit)M75257027420, Serial/Lot Numbers: 22252489778
Recall started: Nov. 2, 2022
Device type: Ear, Nose, And Throat Surgical Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0514-2023

Henry Schein…

Product: HENRY SCHEIN, OMFS, Item No.570-2779,
Quantity: 90 units
Codes and lots: UDI/DI (case) H65857027791, UDI/DI (kit)M75257027790, Serial/Lot Numbers: 22262489585, 22270490757
Recall started: Nov. 2, 2022
Device type: General Purpose Dental Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0515-2023

Henry Schein…

Product: HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
Quantity: 5 units
Codes and lots: UDI/DI (case) H65857027831, UDI/DI (kit)M75257027830, Serial/Lot Numbers: 22234489305
Recall started: Nov. 2, 2022
Device type: Orthopedic Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0516-2023

Henry Schein…

Product: HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
Quantity: 675 units
Codes and lots: UDI/DI (case) H65857027871, UDI/DI (kit)M75257027870, Serial/Lot Numbers: 22262491981
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0517-2023

Henry Schein…

Product: HENRY SCHEIN, CATH PACK Item No.570-2789
Quantity: 100 units
Codes and lots: UDI/DI (case) H65857027891, UDI/DI (kit)M75257027890, Serial/Lot Numbers: 22252491561
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0518-2023

Henry Schein…

Product: HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Quantity: 18 units
Codes and lots: UDI/DI (case) H65857027931, UDI/DI (kit)M75257027930, Serial/Lot Numbers: 22241489575
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0519-2023

Henry Schein…

Product: HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
Quantity: 24 units
Codes and lots: UDI/DI (case) H65857028831, UDI/DI (kit)M75257028831, Serial/Lot Numbers: 22229489323
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0520-2023

Henry Schein…

Product: HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
Quantity: 25 units
Codes and lots: UDI/DI (case) H65857028901, UDI/DI (kit)M75257028900, Serial/Lot Numbers: 22262492001
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0521-2023

Henry Schein…

Product: HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Quantity: 144 units
Codes and lots: UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0522-2023

Henry Schein…

Product: HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
Quantity: 10 units
Codes and lots: UDI/DI (case) H65857029001, UDI/DI (kit)M75257029000, Serial/Lot Numbers: 22252489760
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0523-2023

Henry Schein…

Product: HENRY SCHEIN, Knee Pack, Item No.570-2908,
Quantity: 48 units
Codes and lots: UDI/DI (case) H65857029081, UDI/DI (kit)M75257029080, Serial/Lot Numbers: 22241489773
Recall started: Nov. 2, 2022
Device type: Orthopedic Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0524-2023

Henry Schein…

Product: HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
Quantity: 16 units
Codes and lots: UDI/DI (case) H65857029301, UDI/DI (kit)M75257029300, Serial/Lot Numbers: 22235490920
Recall started: Nov. 2, 2022
Device type: Angiography/Angioplasty Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0525-2023

Henry Schein…

Product: HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
Quantity: 144 units
Codes and lots: UDI/DI (case) H65857029461, UDI/DI (kit)M75257029460, Serial/Lot Numbers: 22242490745
Recall started: Nov. 2, 2022
Device type: Orthopedic Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0526-2023

Henry Schein…

Product: HENRY SCHEIN, Amnio Tray, Item No.570-3059,
Quantity: 510 units
Codes and lots: UDI/DI (case) H65857030591, UDI/DI (kit)M75257030590, Serial/Lot Numbers: 22257487536
Recall started: Nov. 2, 2022
Device type: Sampler, Amniotic Fluid (Amniocentesis Tray)
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0527-2023

Henry Schein…

Product: HENRY SCHEIN, RHINO PACK, Item No.570-3070
Quantity: 328 units
Codes and lots: UDI/DI (case) H65857030701, UDI/DI (kit)M75257030700, Serial/Lot Numbers: 22235491255, 22241491256
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0528-2023

Henry Schein…

Product: HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Quantity: 27 units
Codes and lots: UDI/DI (case) H65857030721, UDI/DI (kit)M75257030720, Serial/Lot Numbers: 22241490953
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0529-2023

Henry Schein…

Product: HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Quantity: 80 units
Codes and lots: UDI/DI (case) H65857030891, UDI/DI (kit)M75257030890, Serial/Lot Numbers: 22251491690
Recall started: Nov. 2, 2022
Device type: Epidural Anesthesia Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0530-2023

Henry Schein…

Product: HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
Quantity: 72 units
Codes and lots: UDI/DI (case) H65857030911, UDI/DI (kit)M75257030910, Serial/Lot Numbers: 22258490762
Recall started: Nov. 2, 2022
Device type: Bone Marrow Biopsy Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0531-2023

Henry Schein…

Product: HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Quantity: 581 units
Codes and lots: UDI/DI (case) H65857030921, UDI/DI (kit)M75257030920, Serial/Lot Numbers: 22231491193
Recall started: Nov. 2, 2022
Device type: Bone Marrow Biopsy Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0532-2023

Henry Schein…

Product: HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
Quantity: 42 units
Codes and lots: UDI/DI (case) H65857031181, UDI/DI (kit)M75257031180, Serial/Lot Numbers: 22234491292
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0533-2023

Henry Schein…

Product: HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
Quantity: 140 units
Codes and lots: UDI/DI (case) H65857031311, UDI/DI (kit)M75257031310, Serial/Lot Numbers: 22257490596
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0534-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
Quantity: 300 units
Codes and lots: UDI/DI (case) M75260060GCTS1, UDI/DI (kit)M75260060GCTS0, Serial/Lot Numbers: 22257490438
Recall started: Nov. 2, 2022
Device type: Syringe, Periodontic, Endodontic, Irrigating
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0535-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Lipo, Item No.681-254,
Quantity: 6 units
Codes and lots: UDI/DI (case) M7526812541, UDI/DI (kit)M7526812540, Serial/Lot Numbers: 22270492010
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0536-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Quantity: 15 units
Codes and lots: UDI/DI (case) M7526820011, UDI/DI (kit)M7526820010, Serial/Lot Numbers: 22236489633
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0537-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Quantity: 5 units
Codes and lots: UDI/DI (case) M7268212281, UDI/DI (kit)M7268212280, Serial/Lot Numbers: 22237491041
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0538-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
Quantity: 40 units
Codes and lots: UDI/DI (case) M7526821301, UDI/DI (kit)M7526821300, Serial/Lot Numbers: 22237491040
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0539-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Phleb, Item No.682-1425,
Quantity: 20 units
Codes and lots: UDI/DI (case) M75268214251, UDI/DI (kit)M75268214250, Serial/Lot Numbers: 22236490624
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0540-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
Quantity: 20 units
Codes and lots: UDI/DI (case) M75268215831, UDI/DI (kit)M75268215830, Serial/Lot Numbers: 22237491038
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0541-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
Quantity: 40 units
Codes and lots: UDI/DI (case) M75268217281, UDI/DI (kit)M75268217280, Serial/Lot Numbers: 22235489419
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0542-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Vein, Item No.682-1732,
Quantity: 10 units
Codes and lots: UDI/DI (case) M75268217321, UDI/DI (kit)M75268217320, Serial/Lot Numbers: 22230489185
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0543-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Quantity: 100 units
Codes and lots: UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509
Recall started: Nov. 2, 2022
Device type: Angiography/Angioplasty Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0544-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
Quantity: 400 units
Codes and lots: UDI/DI (case) M7526821942NL11, UDI/DI (kit)M7526821942NL10, Serial/Lot Numbers: 22251491808
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0545-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Quantity: 30 units
Codes and lots: UDI/DI (case) M7526821993R11, UDI/DI (kit)M7526821993R10, Serial/Lot Numbers: 22235491208
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0546-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
Quantity: 40 units
Codes and lots: UDI/DI (case) M7526823301, UDI/DI (kit)M7526823300, Serial/Lot Numbers: 22238490518
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0547-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Quantity: 10 units
Codes and lots: UDI/DI (case) M752682334R11, UDI/DI (kit)M752682334R10, Serial/Lot Numbers: 22231489619
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0548-2023

www.StradisHealthcare.com…

Product: www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
Quantity: 10 units
Codes and lots: UDI/DI (case) M7526824941, UDI/DI (kit)M7526824940, Serial/Lot Numbers: 22234489198
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0549-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Quantity: 25 units
Codes and lots: UDI/DI (case) M7526825091, UDI/DI (kit)M7526825090, Serial/Lot Numbers: 22256490827
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0550-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Vein, Item No.682-577,
Quantity: 15 units
Codes and lots: UDI/DI (case) M7526825771, UDI/DI (kit)M7526585770, Serial/Lot Numbers: 22230490618
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0551-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Quantity: 105 units
Codes and lots: UDI/DI (case) M7526829471, UDI/DI (kit)M7526829470, Serial/Lot Numbers: 22236491032
Recall started: Nov. 2, 2022
Device type: Cardiovascular Procedure Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0552-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
Quantity: 10
Codes and lots: UDI/DI (case) M7526861421, UDI/DI (kit)M7526861420, Serial/Lot Numbers: 22236491028
Recall started: Nov. 2, 2022
Device type: Angiography/Angioplasty Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0553-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
Quantity: 24 units
Codes and lots: UDI/DI (case) M7526861991, UDI/DI (kit)M7526861990, Serial/Lot Numbers: 22236491017
Recall started: Nov. 2, 2022
Device type: Angiography/Angioplasty Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0554-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, Breast, Item No.693-276,
Quantity: 16 units
Codes and lots: UDI/DI (case) M7526932761, UDI/DI (kit)M7526932760, Serial/Lot Numbers: 22242490001
Recall started: Nov. 2, 2022
Device type: Plastic Surgery And Accessories Kit
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0555-2023

Henry Schein…

Product: HENRY SCHEIN, Vas Pack, Item No.888-2520,
Quantity: 304 units
Codes and lots: UDI/DI (case) H65888825201, UDI/DI (kit)M75288825200, Serial/Lot Numbers: 22256490684
Recall started: Nov. 2, 2022
Device type: General Surgery Tray
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0556-2023

Henry Schein…

Product: HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Quantity: 3 units
Codes and lots: UDI/DI (case) H65888825491, UDI/DI (kit)M75288825490, Serial/Lot Numbers: 22230489459
Recall started: Nov. 2, 2022
Device type: Vasovasostomy Set
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0557-2023

Stradis Healthcare…

Product: STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
Quantity: 75 units
Codes and lots: UDI/DI (case) M752SS0772251, UDI/DI (kit)M752SS0772251, Serial/Lot Numbers: 22255490439
Recall started: Nov. 2, 2022
Device type: Evacuator, Oral Cavity
Root cause (FDA): Packaging process control
What the company told customers: Stradis Healthcare issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 11/2/2022 by email. The notice explained the problem, risk, and requested the following action be taken: Please examine your inventory and immediately quarantine any affected product. Please contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Care can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. In the event you further distributed the affected kits, please identify your customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. Your customers may contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Alternatively, if they communicate through you, we ask that you immediately inform Stradis Healthcare as you become aware. Notification to your customers may be enhanced by including a copy of this recall letter. Stradis Healthcare is also requesting return of the attached Recall Acknowledgement Form to confirm receipt of this recall communication and that you have taken all necessary actions as described above.
Recall number: Z-0558-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0481-2023, Z-0482-2023, Z-0483-2023, Z-0484-2023, Z-0485-2023, Z-0486-2023, Z-0487-2023, Z-0488-2023 and others. The agency record governs; check it and the company before acting.

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