American Contract Systems, Inc.: American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack 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: 15 kits Lot/code info: (1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 00191072201126; Lot 988241;Exp. Date 1/12/2025; (3) Model No CETJ13O; UDI-DI 00191072202017; Lot 989241;Exp. Date 1/11/2025.

UPC codes

00191072201546, 00191072201126, 00191072202017

Source

Official record: FDA (Device enforcement) ↗

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