BEUDAMED
    FDA Recall Terminated

    Olympus JF-140F duodenoscopes (Model NumberJF-140F)

    Recall: Z-2269-2018 · Initiated May 11, 2018

    Recall

    Recall Number
    Z-2269-2018
    Event Number
    79998
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FET
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 11, 2018
    Terminated
    May 5, 2020
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus JF-140F duodenoscopes (Model NumberJF-140F)

    Reason

    Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.

    Action

    Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business

    Distribution

    Nationwide

    Quantity

    994