BEUDAMED
    FDA Recall Terminated

    Hemotherm CE, model 400CE, Heater-Cooling Device

    Recall: Z-1825-2017 · Initiated March 9, 2017

    Recall

    Recall Number
    Z-1825-2017
    Event Number
    76718
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 9, 2017
    Terminated
    December 18, 2017
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    Hemotherm CE, model 400CE, Heater-Cooling Device

    Reason

    Improperly rated fuses were used in the manufacture of the device.

    Action

    Letters were sent to customers and distributors instructing them to immediately cease use and/or further distribution of affected product, remove and discard the affected fuses and replace with the new fuses provided by CSZ, and complete and return the Field Action Response Form.

    Distribution

    Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accounts for this recall. There is one (1) Mexico account for this recall: Koolfer S.A. DE C.V., San Isidro 168, Col. Pedregal De Santa Ursula Coapa, Del. Coyoacan, CP. Mexico D. F. 04600. There is one (1) government account for this recall: WRNMMC -PAA, 8965 Brown Dr, Bethesda, MD 20889.

    Quantity

    390 devices