The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.
Reason for recall: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. Distribution: International distribution to the country of France. Quantity: 1,532 units Lot/code info: Lot Code: UDI carton box: 23700911900123 & UDI bag: 13700911900126 (for US reference). The product reference recalled in France is different and there is no UDI on this one (not required for medicine in France). Batches concerned by the recall are the following: Lot SL240261-1 Lot SL240266-1 Lot SL240272-1 Lot SL240280-2 These batches have been sold only in France
23700911900123, 13700911900126
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.