Device 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.
Z-2162-2013
Product summary
- Event
- Event 65905
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,800 boxes (5,590 full boxes)
- Official record key
device-enforcement:Z-2162-2013
Official wording
Reason: TempaDot products may have been mislabeled.
Code information: Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225
Distribution pattern: Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
Derived failure modes
-
Labeling or packaging
mislabeled