BEUDAMED
    FDA Enforcement Class II Terminated

    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet. Product Usage: Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.

    Recall: Z-0412-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0412-2016
    Event ID
    72686
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bestmed, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 23, 2015
    Initiation Date
    November 12, 2015
    Classification Date
    December 16, 2015
    Termination Date
    November 30, 2016
    Address
    331 Corporate Cirle Unit E, N/A, Golden, CO, 80401, United States

    Description

    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet. Product Usage: Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.

    Reason

    An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.

    Code Info

    Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715"

    Distribution

    US Nationwide Distribution and the country of Canada.

    Quantity

    305,548