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FDA (Device enforcement)Recalled 2025-03-13class ii

INSTITUT GEORGES LOPEZ: Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical devi

Hazard

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

Details from the source

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

UPC codes

23700911900123, 13700911900126

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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