Device product
ROBOTIC URO/GYN PACK. Medical convenience kit.
Z-2263-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 372 units
- Official record key
device-enforcement:Z-2263-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.