Device product
American Contract Systems Gyn Laparoscopy convenience kit
Z-2518-2024
Product summary
- Event
- Event 94908
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 kits
- Official record key
device-enforcement:Z-2518-2024
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 SLGL64K - UDI-DI 00191072202017; Lot 981241; Exp. Date 1/19/2025; and (2) Model No SMGY46A - UDI-DI 00191072188458; Lot 982241; Exp. Date 1/18/2025.
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