BEUDAMED
    FDA Enforcement Class II Terminated

    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

    Recall: Z-2596-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2596-2016
    Event ID
    73607
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Conmed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    May 18, 2016
    Classification Date
    August 19, 2016
    Termination Date
    May 24, 2018
    Address
    310 Broad St, Utica, NY, 13501-1203, United States

    Description

    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.

    Reason

    A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.

    Code Info

    Beginning Lot Code 141001X with Ending Lot Code 20150705X.

    Distribution

    Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.

    Quantity

    4,480 units