Device product
GENERAL ROBOTIC PACK. Medical convenience kit.
Z-2248-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 203 units
- Official record key
device-enforcement:Z-2248-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NAFB082-04, NAMC473-01; UDI: 10809160395691, 10809160375037; Kit Lot No. 1568211, 1576237, 1599515, 1599516, 1605944, 1613558, 1616420, 1613626, 1625831, 1627259, 1628672, 1632042, 1635911.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.