BEUDAMED
    FDA Recall Terminated

    Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R

    Recall: Z-0815-04 · Initiated March 25, 2004

    Recall

    Recall Number
    Z-0815-04
    Event Number
    28638
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2004
    Posted
    July 20, 2004
    Terminated
    November 23, 2005
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R

    Reason

    An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

    Action

    A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm.

    Distribution

    The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.

    Quantity

    132 units