Device product
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
Z-2258-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-2258-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. NIHB0022-09, NIHB0022-11, NIHB0022-12; UDI: 10809160381311, 10809160403730, 10809160440940; Kit Lot No. 1580032, 1590461, 1590463, 1604743, 1613180, 1613182, 1618989, 1641040.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.