Device product
American Contract Systems Biopsy Drape Pack convenience kit
Z-2523-2024
Product summary
- Event
- Event 94908
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 224
- Official record key
device-enforcement:Z-2523-2024
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: UDI-DI 00191072202246; Lot 981241; Exp. Date 1/19/2025
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