BEUDAMED
    FDA Recall Terminated

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    Recall: Z-2290-2014 · Initiated July 17, 2014

    Recall

    Recall Number
    Z-2290-2014
    Event Number
    68753
    Firm
    Pentax Medical Company
    FEI Number
    1000080301
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 17, 2014
    Posted
    August 21, 2014
    Terminated
    August 20, 2015
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    Reason

    The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

    Action

    Pentax Medical sent an Urgent Medical Device Recall Field Safety Corrective Action letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the Instruction for Use are not followed carefully by the user there is a potential risk to health for the patient, such as a perforation. Customers are asked to complete the attached response form and fax to (201) 799-4063. Customers should see the attached revised Instructions for Use Z632 R09. If you have any questions regarding this action, please feel free to contact your Sales Representative at : 800-431-5880 ext 2064

    Distribution

    Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.

    Quantity

    98 units US; 1108 units OUS