Device product
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Z-2260-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46 units
- Official record key
device-enforcement:Z-2260-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NIHB0035-07; UDI: 10809160404959; Kit Lot No. 1591938, 1622268, 1628944, 1632685.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.