PlainRecordsFDA · Medical device recall
Tenaculum… and 5 more products
- Date
- Oct. 27, 2021
- 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
- Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
- Distribution pattern
- Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.
6 products in this recall
Tenaculum…
- Product
- Tenaculum, Plastic
- Quantity
- 2483 kits
- Codes and lots
- Part Number: 356T
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0126-2022
IUD Insertion Pack
- Product
- IUD Insertion Pack
- Quantity
- 20 kits
- Codes and lots
- Part Number: 618-034
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0127-2022
IUD Insertion Kit
- Product
- IUD Insertion Kit
- Quantity
- 14959 kits
- Codes and lots
- Part Number: 935K
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0128-2022
Endometrial Biopsy Kit
- Product
- Endometrial Biopsy Kit
- Quantity
- 1639 kits
- Codes and lots
- Part Number: 936K
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0129-2022
Foundation Kit
- Product
- Foundation Kit
- Quantity
- 790 kits
- Codes and lots
- Part Number: A10
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0130-2022
Standard IUD Insertion Kit
- Product
- Standard IUD Insertion Kit
- Quantity
- 280 kits
- Codes and lots
- Part Number: M20
- Recall started
- Sept. 10, 2021
- Device type
- Tenaculum, Uterine
- Root cause (FDA)
- Device Design
- What the company told customers
- The firm distributed the recall notice titled, "URGENT: MEDICAL DEVICE RECALL" to all affected consignees via first class mail on September 10, 2021. The letter instructs the consignee to examine their inventory and immediately quarantine any affected product. The consignee is to contact Stradis Customer Care to arrange for return shipment of the recalled product along with a full refund, credit or product substitute. In the event that the consignee further distributed the affected surgical kits, they are to identify their customers, and notify them within forty-eight (48) hours of receipt of this recall notification to inform them of this issue. The consignee's customers should contact Stradis Customer Care to arrange for any of the affected surgical kits to be returned to Stradis Healthcare and credited accordingly. Notification to the consignee's 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 the consignee has taken all necessary actions as described above.
- Recall number
- Z-0131-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0126-2022, Z-0127-2022, Z-0128-2022, Z-0129-2022, Z-0130-2022, Z-0131-2022. The agency record governs; check it and the company before acting.