BEUDAMED
    FDA Enforcement Class II Terminated

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    Recall: Z-2130-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2130-2016
    Event ID
    74311
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Ultrasonics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    May 6, 2016
    Classification Date
    July 6, 2016
    Termination Date
    April 18, 2017
    Address
    144 Railroad Dr, N/A, Ivyland, PA, 18974-1449, United States

    Description

    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

    Reason

    To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.

    Code Info

    All serial numbers

    Distribution

    Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.

    Quantity

    2,345 units