Device product
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Z-3148-2024
Product summary
- Event
- Event 95186
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-3148-2024
Official wording
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Code information: GTIN/UDI 0871472932327, Lot # 33512376, exp. 02/26/2027
Distribution pattern: US, Colombia, Philippines, Russia
Derived failure modes
-
Unknown
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.