American Contract Systems, Inc.: American Contract Systems Gyn Laparoscopy convenience kit

Hazard

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

Details from the source

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: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD. Quantity: 29 kits Lot/code info: (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.

UPC codes

00191072202017, 00191072188458

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.