BEUDAMED
    FDA Recall Terminated

    XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.

    Recall: Z-2795-2011 · Initiated May 12, 2011

    Recall

    Recall Number
    Z-2795-2011
    Event Number
    58824
    Firm
    Vitrolife, Inc.
    FEI Number
    3003274090
    Product Code
    MSB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 12, 2011
    Posted
    July 12, 2011
    Terminated
    July 15, 2011
    Address
    3601South Inca Street, Englewood, CO, 80110

    Description

    XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.

    Reason

    Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.

    Action

    XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933

    Distribution

    Worldwide distribution including USA and Europe.

    Quantity

    1457 bottles