BEUDAMED
    FDA Recall Terminated

    CryoValve Pulmonary Valve and Conduit

    Recall: Z-1057-04 · Initiated June 17, 2004

    Recall

    Recall Number
    Z-1057-04
    Event Number
    29451
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2004
    Posted
    July 20, 2004
    Terminated
    March 7, 2005
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve Pulmonary Valve and Conduit

    Reason

    The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).

    Action

    Consignees were notified by letter on 06/17/2004 and 06/18/2004.

    Distribution

    CA, OH, OR, PA.

    Quantity

    3 unit