BEUDAMED
    FDA Enforcement Class II Terminated

    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

    Recall: Z-0760-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0760-2016
    Event ID
    72756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    November 10, 2015
    Classification Date
    February 5, 2016
    Termination Date
    April 21, 2017
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

    Reason

    Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.

    Code Info

    All lots/serial numbers sold prior to August 2014.

    Distribution

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

    Quantity

    1,539