Device product
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Z-0866-2022
Product summary
- Event
- Event 89671
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 348 units
- Official record key
device-enforcement:Z-0866-2022
Official wording
Reason: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Code information: SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
Distribution pattern: US Nationwide distribution in the states of IN, TX, and PA.
Derived failure modes
-
Sterility assurance
bag may be perforated or torn, which may result in a breach in the sterility