BEUDAMED
    FDA Enforcement Class I Terminated

    PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

    Recall: Z-0084-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0084-2014
    Event ID
    66379
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    September 16, 2013
    Classification Date
    October 28, 2013
    Termination Date
    July 9, 2014
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

    Reason

    PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

    Code Info

    Model OF-B194

    Distribution

    Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.

    Quantity

    76 units