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: 5,588 bags Lot/code info: Lot: 36-239526, Exp. 7/12/2023; 36-239993, Exp. 7/13/2023; 36-240796, Exp. 7/17/2023; 36-241982, Exp. 7/24/2023; 36-242696, Exp. 7/26/2023; 36-243161, Exp. 7/27/2023; 36-243954, Exp. 7/31/2023; 36-245534, Exp. 8/2/2023; 36-247885, Exp. 8/10/2023; 36-248977, 36-249137, Exp. 8/16/2023; 36-251052, Exp. 8/24/2023; 36-251705, 36-251706, Exp. 8/29/2023; 36-252190, Exp. 8/31/2023; 36-255490, 36-255492, 36-255494, Exp. 9/7/2023.
Official record: FDA (Drug enforcement) ↗
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