BEUDAMED
    FDA Recall Terminated

    Aortic Valve & Conduit

    Recall: Z-0859-05 · Initiated May 17, 2005

    Recall

    Recall Number
    Z-0859-05
    Event Number
    32127
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 17, 2005
    Posted
    June 1, 2005
    Terminated
    June 1, 2005
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    Aortic Valve & Conduit

    Reason

    Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.

    Action

    Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.

    Distribution

    IL, MT

    Quantity

    1 unit