Device product
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Z-2244-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 626 units
- Official record key
device-enforcement:Z-2244-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.