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
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.
00191072198730, 00191072190093
Official record: FDA (Device enforcement) ↗
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