Recall Z-3148-2024 ยท FFA Tube, Drainage, Suprapubic
Boston Scientific Corporation
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
| Date | Sep 13, 2024 (initiated Jul 18, 2024) |
| Status | Open, Classified |
| Reason | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 32 units |
| Distribution | US, Colombia, Philippines, Russia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211934 | APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dis Boston Scientific Corporation, Nov 10, 2022 |