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FDA (Device enforcement)Recalled 2024-05-06class ii

American Contract Systems, Inc.: American Contract Systems Special Procedure 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: 112 Lot/code info: (1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.

UPC codes

00191072198730, 00191072190093

Source

Official record: FDA (Device enforcement)

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

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