Device product
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Z-2247-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 574 units
- Official record key
device-enforcement:Z-2247-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. EURO010-08, USAR042-17, WILF006-29; UDI: 10809160414309, 10809160400586, 10809160429914, 10809160431108; Kit Lot No. 1616570, 1581675, 1594938, 1597550, 1600846, 1620149, 1620150, 1620151, 1622920.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.