Device product
LAVH PACK. Medical convenience kit.
Z-2257-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 292 units
- Official record key
device-enforcement:Z-2257-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. USAR053-11; UDI: 10809160372357; Kit Lot No. 1578109, 1585712, 1597106, 1601742, 1601643, 1607925, 1612044, 1621429, 1637117.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.