BEUDAMED
    FDA Recall Terminated

    Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

    Recall: Z-3042-2017 · Initiated March 31, 2017

    Recall

    Recall Number
    Z-3042-2017
    Event Number
    77794
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 31, 2017
    Posted
    August 16, 2017
    Terminated
    August 28, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US

    Reason

    Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.

    Action

    Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.

    Distribution

    Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA

    Quantity

    3,450 units