BEUDAMED
    FDA Recall Terminated

    Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN

    Recall: Z-1110-2007 · Initiated April 18, 2007

    Recall

    Recall Number
    Z-1110-2007
    Event Number
    37273
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 18, 2007
    Posted
    July 26, 2007
    Terminated
    November 1, 2007
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN

    Reason

    Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic.

    Action

    The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.

    Distribution

    Nationwide: Distributed to states of CO and PA

    Quantity

    11 units