BEUDAMED
    FDA Recall Open, Classified

    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 device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36 to 46F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    Recall: Z-2220-2025 · Initiated March 13, 2025

    Recall

    Recall Number
    Z-2220-2025
    Event Number
    96793
    Firm
    INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France
    FEI Number
    3024820181
    Product Code
    MSB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 13, 2025
    Posted
    July 30, 2025

    Description

    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 device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36 to 46F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).

    Reason

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

    Action

    On March 13, 2025 notification emails were sent to OUS customers informing them of the recall and instructing them to check their inventory for affected product and to destroy it. If they did not wish to destroy, to arrange for the product to be returned to the recalling firm. Customers were instructed to acknowledge receipt of the email and provide proof of destruction, if performed.

    Distribution

    International distribution to the country of France.

    Quantity

    1,532 units