BEUDAMED
    FDA Recall Terminated

    Jostra HL-20 Heart Lung Machine - guiding pins

    Recall: Z-0159-2007 · Initiated October 3, 2006

    Recall

    Recall Number
    Z-0159-2007
    Event Number
    36255
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 3, 2006
    Posted
    November 7, 2006
    Terminated
    December 19, 2007
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Jostra HL-20 Heart Lung Machine - guiding pins

    Reason

    The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.

    Action

    An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.

    Distribution

    Worldwide

    Quantity

    227 HL-20 base units with 545 single pumps