BEUDAMED
    FDA Recall Terminated

    Heart-valve, allograft

    Recall: Z-1187-03 · Initiated February 4, 2003

    Recall

    Recall Number
    Z-1187-03
    Event Number
    25772
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 4, 2003
    Posted
    August 28, 2003
    Terminated
    August 28, 2003
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144

    Description

    Heart-valve, allograft

    Reason

    Donor of aortic valve had procurement cultures that were positive for E-coli.

    Action

    A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.

    Distribution

    Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.

    Quantity

    1 unit