Z-2518-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- May 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 kits
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
Distribution Pattern
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.