BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit

    Recall: Z-0516-04 · Initiated November 10, 2003

    Recall

    Recall Number
    Z-0516-04
    Event Number
    27949
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 10, 2003
    Posted
    February 10, 2004
    Terminated
    May 6, 2004
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve & Conduit

    Reason

    The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.

    Action

    Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.

    Distribution

    The tissue was issued to one hospital in CA.

    Quantity

    1 unit