BEUDAMED
    FDA Recall Open, Classified

    CryoValve SG Cryopreserved Pulmonary Human Heart Valve

    Recall: Z-1545-2024 · Initiated March 6, 2024

    Recall

    Recall Number
    Z-1545-2024
    Event Number
    94250
    Firm
    Artivion, Inc
    FEI Number
    3001451326
    Product Code
    OHA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 6, 2024
    Posted
    April 16, 2024
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve SG Cryopreserved Pulmonary Human Heart Valve

    Reason

    The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

    Action

    The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.

    Distribution

    US Nationwide distribution in the state of Ohio.

    Quantity

    1 unit