Recall Z-2162-2013— Medical Indicators, Inc.
Class II · Terminated
Class II FDA medical device recall by Medical Indicators, Inc., initiated 2013-07-10, terminated 2014-01-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Medical Indicators, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-10
- Terminated
- 2014-01-16
- Firm location
- Hamilton, NJ, United States
Product 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 for recall
TempaDot products may have been mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.