BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0760-2016 · Initiated November 10, 2015

    Recall

    Recall Number
    Z-0760-2016
    Event Number
    72756
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    November 10, 2015
    Posted
    February 5, 2016
    Terminated
    April 21, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    Bard Medical Division sent a Safety Alert to each of the customers via FedEx with proof of delivery notice. All consignees have been instructed to carry the notification out to the user-level.

    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