Device product
GYN ROBOTIC PACK. Medical convenience kit.
Z-2251-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 45 units
- Official record key
device-enforcement:Z-2251-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NAMC474-01; UDI: 10809160375044; Kit Lot No. 1620573, 1620572, 1621883, 1621884, 1628673.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.