BEUDAMED
    FDA Recall Terminated

    Pulmonary Valve & Conduit SG Used in heart surgery

    Recall: Z-1219-2011 · Initiated January 7, 2011

    Recall

    Recall Number
    Z-1219-2011
    Event Number
    57730
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 7, 2011
    Posted
    February 11, 2011
    Terminated
    November 1, 2011
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    Pulmonary Valve & Conduit SG Used in heart surgery

    Reason

    A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.

    Action

    The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.

    Distribution

    Nationwide distribution: USA state of: MI

    Quantity

    One