BEUDAMED
    FDA Enforcement Class II Terminated

    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.

    Recall: Z-2162-2013 · Reported September 18, 2013

    Enforcement

    Recall Number
    Z-2162-2013
    Event ID
    65905
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Indicators, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2013
    Initiation Date
    July 10, 2013
    Classification Date
    September 6, 2013
    Termination Date
    January 16, 2014
    Address
    16 Thomas J. Rhodes Industrial Drive, N/A, Hamilton, NJ, 08619, United States

    Description

    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.

    Reason

    TempaDot products may have been mislabeled.

    Code Info

    Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225

    Distribution

    Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.

    Quantity

    111,800 boxes (5,590 full boxes)