Device product
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
Z-2261-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52 units
- Official record key
device-enforcement:Z-2261-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NAMC077, NAMC077-02; UDI: 10809160318911, 10809160437971; Kit Lot No. 1591073, 1612261, 1616916, 1632036, 1632038, 1632359.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.