Device product
PACK GENERAL ROBOTIC. Medical convenience kit.
Z-2259-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 656 units
- Official record key
device-enforcement:Z-2259-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: Model No. RDLD047-10; UDI: 10809160358603; Kit Lot No. 1589630, 1590570, 1610157, 1617028, 1618142, 1621537, 1629589, 1635288, 1636852.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.