Device product
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
Z-2521-2024
Product summary
- Event
- Event 94908
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-2521-2024
Official wording
Reason: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Code information: (1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 00191072201126; Lot 988241;Exp. Date 1/12/2025; (3) Model No CETJ13O; UDI-DI 00191072202017; Lot 989241;Exp. Date 1/11/2025.
Distribution pattern: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Derived failure modes
-
Unknown
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility