Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drain
FDA device recall Z-3147-2024 · posted 2024-09-13 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- 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.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- FFA
- Quantity affected
- 89 units
- Distribution
- US, Colombia, Philippines, Russia
- Date initiated
- 2024-07-18
- Date posted
- 2024-09-13
- Location
- Maple Grove, MN
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