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Recall Observatory FDA recall evidence

Device product

American Contract Systems Gyn Laparoscopy convenience kit

Z-2518-2024

May 06, 2024

Class II

Product summary

Firm
American Contract Systems, Inc.
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

    reason.no_named_rule · v1.0.0

    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