Device product
LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.
Z-2255-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-2255-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NIHB0036-07; UDI: 10809160403099; Kit Lot No. 1589877, 1612565.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.