BEUDAMED
    FDA Recall Terminated

    Arctic Sun Temperature Management System

    Recall: Z-0436-05 · Initiated January 5, 2005

    Recall

    Recall Number
    Z-0436-05
    Event Number
    30896
    Firm
    MEDIVANCE INC.
    FEI Number
    3003329224
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2005
    Posted
    January 26, 2005
    Terminated
    March 25, 2005
    Address
    1172 W Century Dr, Ste 240, Louisville, CO, 80027-1681

    Description

    Arctic Sun Temperature Management System

    Reason

    Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

    Action

    US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.

    Distribution

    AL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.

    Quantity

    67 units