BEUDAMED
    FDA Recall Terminated

    Aortic Valve & Conduit

    Recall: Z-0842-2007 · Initiated April 17, 2007

    Recall

    Recall Number
    Z-0842-2007
    Event Number
    37876
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2007
    Posted
    June 7, 2007
    Terminated
    December 31, 2007
    Address
    1655 Roberts Blvd. NW, Kennesaw, GA, 30144-3632

    Description

    Aortic Valve & Conduit

    Reason

    Donor tissue was released prior to information received regarding a pericardial effusion.

    Action

    Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife

    Distribution

    AZ, CO

    Quantity

    1 tissue