BEUDAMED
    FDA Recall Terminated

    Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.

    Recall: Z-0108-2008 · Initiated September 20, 2007

    Recall

    Recall Number
    Z-0108-2008
    Event Number
    44929
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    LQC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 20, 2007
    Posted
    October 31, 2007
    Terminated
    February 15, 2008
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.

    Reason

    Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath

    Action

    The recalling firm issued a recall letter dated 9/20/07 to the medical facilities informing them of the problem and the need to return the product. The letter also informed the hospitals that replacement products would be sent.

    Distribution

    Nationwide

    Quantity

    37 units