FDA Recall
Open, Classified
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Recall: Z-3149-2024
·
Initiated July 18, 2024
Recall
- Recall Number
- Z-3149-2024
- Event Number
- 95186
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- FFA
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- July 18, 2024
- Posted
- September 13, 2024
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
Description
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Reason
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Action
Boston Scientific issued am Urgent Medical Device Removal notice to it consignees on 07/18/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the return of the devices. Consignees were directed to post the notice in a visible location near the affected products to ensure visibility and to share the notice with all those to whom the device was transferred. Distributors were direct to notify their customers.
Distribution
US, Colombia, Philippines, Russia
Quantity
10 units