BEUDAMED
    FDA Recall Terminated

    CryoValve, Pulmonary Valve & Conduit SG

    Recall: Z-0218-06 · Initiated November 19, 2003

    Recall

    Recall Number
    Z-0218-06
    Event Number
    32850
    Firm
    Cryolife Inc
    FEI Number
    3001451326
    Product Code
    MIE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2003
    Posted
    November 30, 2005
    Terminated
    July 2, 2009
    Address
    1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632

    Description

    CryoValve, Pulmonary Valve & Conduit SG

    Reason

    Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.

    Action

    Consignees were notified by letter starting 11/17/2003.

    Distribution

    AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.

    Quantity

    7 units