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: 6,772 bags Lot/code info: Lot: 36-238968, 36-238985, 36-238992, 36-238998, Exp. 7/10/2023; 36-240784, 36-240785, 36-240786, 36-240787, Exp. 7/17/2023; 36-240840, 36-240842, Exp. 7/18/2023; 36-243157, Exp. 7/27/2023; 36-243953, Exp. 7/31/2023; 36-251050, 36-251051, 36-251059, Exp. 8/24/2023; 36-252196, 36-252197, 36-252200, Exp. 8/31/2023; 36-254418, Exp. 9/5/2023; 36-256916, Exp. 9/13/2023.
Official record: FDA (Drug enforcement) ↗
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