BEUDAMED
    FDA Recall Terminated

    Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.

    Recall: Z-0476-2008 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-0476-2008
    Event Number
    45485
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 1, 2007
    Posted
    January 26, 2008
    Terminated
    October 23, 2008
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.

    Reason

    Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

    Action

    Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic .

    Distribution

    Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.

    Quantity

    34