Recall Z-3148-2024
Boston Scientific Corporation · initiated July 18, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Codes / lots: GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Reason for recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-3148-2024
- Initiated
- July 18, 2024
- Posted by FDA
- September 13, 2024
- Product code
- FFA – Tube, Drainage, Suprapubic
- Quantity
- 32 units
- Distribution
- US, Colombia, Philippines, Russia
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3147-2024 Class II | Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b)…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3149-2024 Class II | Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3150-2024 Class II | vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |
| Z-3151-2024 Class II | VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to…There is the potential for holes in the clear sterile barrier of the device pouch which may impact device… | 07/18/2024Open, Classified |