Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Distribution: Nationwide in the USA Quantity: 3,980 bags Lot/code info: Lot: 36-245576, Exp. 8/2/2023; 36-254436, 36-254442, Exp. 9/5/2023; 36-255131, Exp. 9/6/2023; 36-256045, Exp. 9/11/2023; 36-239523, Exp. 7/12/2023; 36-248987, Exp. 8/16/2023; 36-240797, Exp. 7/17/2023; 36-241979, Exp. 7/24/2023; 36-242705, Exp. 7/26/2023; 36-251733, 36-251738, Exp. 8/29/2023.
Official record: FDA (Drug enforcement) ↗
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