American Contract Systems Gyn Laparoscopy convenience kit
FDA Recall #Z-2518-2024 — Class II — May 6, 2024
Product Description
American Contract Systems Gyn Laparoscopy convenience kit
Reason for Recall
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
Recalling Firm
American Contract Systems, Inc. — Kansas City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
29 kits
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated