BEUDAMED
    FDA Recall 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 · Initiated September 16, 2013

    Recall

    Recall Number
    Z-0084-2014
    Event Number
    66379
    Firm
    Pentax Medical Company
    FEI Number
    1000080301
    Product Code
    FCX
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    September 16, 2013
    Posted
    October 28, 2013
    Terminated
    July 9, 2014
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    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.

    Action

    PENTAX Medical sent an "Urgent Device Recall" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. . The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall. The customer was instructed to identify and notify their customers if they further distributed the product. The notification instructs users to return the OF-B194 Valves for replacement with corrected product. Customers were asked to complete the attached response form and fax back to Pentax Medical at 1.201.799.4063. An enclosed UPS Airway Bill is to be used to return recalled product. A contact phone number and email address is provided if the customer has questions (1.800.431.5880 xt2064). For questions regarding this recall call 800-431-5880. Pentax issued a press release on 10/31/2013. Pentax posted their press release on their website at www.pentax.com.

    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