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: 6037 bags Lot/code info: Lot: 36-239496, Exp. 7/12/2023; 36-240256, Exp. 7/17/2023; 36-241134, Exp. 7/19/2023; 36-241928, Exp. 7/23/2023; 36-243835, Exp. 7/31/2023; 36-245010, 36-245011, Exp. 8/1/2023; 36-245529, 36-245532, Exp. 8/2/2023; 36-246255, 36-246256, 36-246258, 36-246259, Exp. 8/3/2023; 36-247806, Exp. 8/9/2023; 36-248035, Exp. 8/10/2023; 36-248367, Exp. 8/11/2023; 36-249506, 36-249507, 36-249508, Exp. 8/18/2023; 36-251436, 36-251437, Exp. 8/28/2023; 36-254396, Exp. 9/4/2023
Official record: FDA (Drug enforcement) ↗
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