PlainRecordsFDA · Medical device recall
Stradis Healthcare Foley Catheter Insertion Tray with preconnected… and 17 more products
- Date
- Jan. 18, 2023
- 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 Healthcare
- Reason
- Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Distribution pattern
- US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
18 products in this recall
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter…
- Product
- Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
- Quantity
- 920 units
- Codes and lots
- a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466
- Recall started
- Dec. 15, 2022
- Device type
- Urinary Drainage Collection Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0931-2023
PHS Lacertaion Tray…
- Product
- PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
- Quantity
- 300 units
- Codes and lots
- Assembly Number 477944, UDI-DI: M7524779441, Lot Numbers: 220974270, 220915145
- Recall started
- Dec. 15, 2022
- Device type
- Laceration Tray
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0932-2023
Henry Shein CYSTO SET UP PACK…
- Product
- Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
- Quantity
- 1,040 units
- Codes and lots
- Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.
- Recall started
- Dec. 15, 2022
- Device type
- Tray, Surgical, Instrument
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0933-2023
Henry Shein GLOVES…
- Product
- Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;
- Quantity
- 21,755 units
- Codes and lots
- Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161. a. Assembly Number 570-1159, UDI-DI: H65857011591, Lot Numbers: 221668682, 222501598, 222308841, 222521158, 222238329, 222276824, 221053079, 221872664; b. Assembly Number 570-1160, UDI-DI: H65857011601, Lot Numbers: 222521156, 222429019, 222428991, 220452660, 222439059, 222428995, 221055116, 222288188, 222501154, 222501155, 222521157, 220762521, 222509319, 222769004, 222639005, 220141429, 222508994; c. Assembly Number 570-1161, UDI-DI: H65857011611, Lot Numbers: 220692475, 222308200, 220251830, 220954105, 220962657, 222248185, 220250698, 222298349, 220251993, 222308198, 222298840, 222521804, 220963077, 220986550, 220141428; d. Assembly Number 570-1162, UDI-DI: H65857011621, Lot Numbers: 221196021, 220462656, 221056018, 221056532, 222308350, 221176016, 221054106, 221056019, 222308552, 222501299, 222501300, 222521301, 220973076, 220896020, 221026017, 213631427; e. Assembly Number 570-1164, UDI-DI: H65857011641, Lot Numbers: 222016037, 222358186, 222430336, 221946035, 222439014, 222430367, 222630366, 222902499, 220252640, 222496579, 221053074, 222350340, 222016033, 222016036, 222146031, 222358129, 222358550, 222496823, 222691515, 220462661, 222692162, 222016034, 222509320, 222692160, 221956029, 220452523, 222016032, 222499000; f. Assembly Number 570-1163, UDI-DI: H65857011631, Lot Numbers: 222290711, 221796024, 221796026, 221796027, 222497161, 222509729, 222510199, 221193075, 222458997, 221024107, 221796025, 222509511, 221796023, 221796022
- Recall started
- Dec. 15, 2022
- Device type
- Personal Protection Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0934-2023
Picc Kit…
- Product
- PICC KIT, 10/CS, ACCESS MEDICAL LABEL
- Quantity
- 180 units
- Codes and lots
- Assembly Number ACC-2550, UDI-DI: M752ACC25501, Lot Number: 220241506
- Recall started
- Dec. 15, 2022
- Device type
- Peripheral Catheter Insertion Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0935-2023
HCT 500mL BAGS…
- Product
- HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
- Quantity
- 644 units
- Codes and lots
- Assembly Number HCT10500, UDI-DI: M752HCT105002, Lot Number: 220602531
- Recall started
- Dec. 15, 2022
- Device type
- Container, I.V.
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0936-2023
HCT 50mL EVA BAGS…
- Product
- HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
- Quantity
- 2,779 units
- Codes and lots
- Assembly Number HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841
- Recall started
- Dec. 15, 2022
- Device type
- Container, I.V.
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0937-2023
HCT 12 CC Syringe Kit…
- Product
- HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
- Quantity
- 112,675 units
- Codes and lots
- Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972
- Recall started
- Dec. 15, 2022
- Device type
- Syringe, Piston
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0938-2023
HCT 6 CC Syringe Kit…
- Product
- HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
- Quantity
- 76,260 units
- Codes and lots
- Assembly Number HCT3916-1, UDI-DI: M752HCT391611, Lot Numbers: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, 221458554
- Recall started
- Dec. 15, 2022
- Device type
- Syringe, Piston
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0939-2023
HCT CENTRAL LINE Insertion Tray…
- Product
- HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
- Quantity
- 1,176 units
- Codes and lots
- Assembly Number HCT8249CP-3, UDI-DI: M752HCT8249CP30, Lot Numbers: 222098152, 222551621, 221010141, 222309118, 222901807
- Recall started
- Dec. 15, 2022
- Device type
- Central Venous Catheter Tray
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0940-2023
HCT MAX BARRIER PICC INSERTION TRAY 12 per case…
- Product
- HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
- Quantity
- 200 units
- Codes and lots
- Assembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373
- Recall started
- Dec. 15, 2022
- Device type
- Central Venous Catheter Tray
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0941-2023
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case…
- Product
- Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
- Quantity
- 2,500 units
- Codes and lots
- Assembly Number MAG-3000, UDI-DI: M752MAG30001, Lot Numbers: 220883387, 221226000, 220960490, 220986568, 222074682, 222458932
- Recall started
- Dec. 15, 2022
- Device type
- Peripheral Catheter Insertion Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0942-2023
McCormick Medical Distribution PORT TRAY…
- Product
- McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
- Quantity
- 250 units
- Codes and lots
- Assembly Number MC-3535PT, UDI-DI: M752MC3535PT1, Lot Numbers: 220673037, 222096813
- Recall started
- Dec. 15, 2022
- Device type
- I.V. Start Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0943-2023
Stradis Healthcare TCTR Convenience Kit…
- Product
- Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
- Quantity
- 80 units
- Codes and lots
- Assembly Number TCTR01, UDI-DI: M752TCTR011, Lot Numbers: 222014334
- Recall started
- Dec. 15, 2022
- Device type
- Tray, Surgical, Instrument
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0944-2023
Tacy Medical…
- Product
- Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
- Quantity
- 1,175 units
- Codes and lots
- Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385
- Recall started
- Dec. 15, 2022
- Device type
- I.V. Start Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0945-2023
Tacy Medical…
- Product
- Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
- Quantity
- 275 units
- Codes and lots
- Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335
- Recall started
- Dec. 15, 2022
- Device type
- I.V. Start Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0946-2023
Tacy Medical…
- Product
- Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
- Quantity
- 600 units
- Codes and lots
- Assembly Number TM8823-1, UDI-DI: M752TM882310, Lot Number: 220110674
- Recall started
- Dec. 15, 2022
- Device type
- I.V. Start Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0947-2023
Vital Care Products NEONATAL PICC TRAY…
- Product
- Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
- Quantity
- 200 units
- Codes and lots
- Assembly Number VCP16515-1, UDI-DI: M765VCP1651511, Lot Number: 221925083
- Recall started
- Dec. 15, 2022
- Device type
- Peripheral Catheter Insertion Kit
- Root cause (FDA)
- Process control
- What the company told customers
- Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
- Recall number
- Z-0948-2023
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0931-2023, Z-0932-2023, Z-0933-2023, Z-0934-2023, Z-0935-2023, Z-0936-2023, Z-0937-2023, Z-0938-2023 and others. The agency record governs; check it and the company before acting.