Device product
DAVINCI UROLOGY. Medical convenience kit.
Z-2245-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 166 units
- Official record key
device-enforcement:Z-2245-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. WRNM038-09, WRNM038-10, WRNM038-11; UDI: 10809160369302, 10809160418338, 10809160432259; Kit Lot No. 1589886, 1593087, 1606686, 1606688, 1615262, 1611133, 1627007.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.