Device product
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Z-3151-2024
Product summary
- Event
- Event 95186
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-3151-2024
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 0871472904856, Lot # 33751204, exp. 04/03/2027
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.