Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 18, 2024
- Posted
- September 13, 2024
- Recall Number
- Z-3147-2024
- Quantity
- 89 units
- Firm Location
- Maple Grove, MN
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
a) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027
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.
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