BEUDAMED
    FDA Recall Terminated

    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

    Recall: Z-2271-2018 · Initiated May 14, 2018

    Recall

    Recall Number
    Z-2271-2018
    Event Number
    80199
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    OHA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 14, 2018
    Terminated
    March 29, 2019
    Address
    1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632

    Description

    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

    Reason

    Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

    Action

    The firm notified the consignees by letter on 05/14/2018.

    Distribution

    AR, OH

    Quantity

    1 unit