Device product
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Z-3149-2024
Product summary
- Event
- Event 95186
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-3149-2024
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 0871472932337, Lot # 33550953, exp. 03/04/2027
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.