Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
This recall is currently active, issued September 13, 2024. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 18, 2024
- Posted
- September 13, 2024
- Recall Number
- Z-3148-2024
- Quantity
- 32 units
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Distribution
US, Colombia, Philippines, Russia
Lot / Code Info
GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Root 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.