BEUDAMED
    FDA Recall Terminated

    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.

    Recall: Z-0329-2014 · Initiated May 20, 2013

    Recall

    Recall Number
    Z-0329-2014
    Event Number
    65352
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    FEQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 20, 2013
    Posted
    November 15, 2013
    Terminated
    October 24, 2016
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.

    Reason

    There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.

    Action

    Notification letters were sent to customers on May 20, 2013.

    Distribution

    Worldwide distribution: USA (nationwide) and the country of Canada.

    Quantity

    263