BEUDAMED
    FDA Enforcement Class II Ongoing

    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 46¿F. 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 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2220-2025
    Event ID
    96793
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    INSTITUT GEORGES LOPEZ
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 6, 2025
    Initiation Date
    March 13, 2025
    Classification Date
    July 30, 2025
    Address
    6 ROUTE DE SAINT BONNET, ST LAURENT DE CHAMOUSSET, N/A, France

    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 46¿F. 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.

    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

    Distribution

    International distribution to the country of France.

    Quantity

    1,532 units