BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2269-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2269-2018
    Event ID
    79998
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    May 11, 2018
    Classification Date
    June 21, 2018
    Termination Date
    May 5, 2020
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    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.

    Code Info

    All

    Distribution

    Nationwide

    Quantity

    994