BEUDAMED
    FDA Enforcement Class II Ongoing

    CryoValve SG Cryopreserved Pulmonary Human Heart Valve

    Recall: Z-1545-2024 · Reported April 24, 2024

    Enforcement

    Recall Number
    Z-1545-2024
    Event ID
    94250
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Artivion, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 24, 2024
    Initiation Date
    March 6, 2024
    Classification Date
    April 16, 2024
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632, United States

    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.

    Code Info

    Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028

    Distribution

    US Nationwide distribution in the state of Ohio.

    Quantity

    1 unit