Z-2162-2013 Class II Terminated
FDA device recall Z-2162-2013 was initiated by Medical Indicators, Inc. on July 10, 2013 and is designated Class II. Reason for recall: TempaDot products may have been mislabeled. The recall status is terminated (terminated January 16, 2014). Affected quantity: 111,800 boxes (5,590 full boxes).
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- July 10, 2013
- Termination Date
- January 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111,800 boxes (5,590 full boxes)
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.
Distribution Pattern
Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
Code Information
Lots 06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225