AUDIENCE: Consumer, Pediatrics
ISSUE: Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N: 3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in November 2015.
Some Digital Temple Thermometers contain a manufacturing problem causing the affected thermometers to display temperatures that are inaccurate and lower than actual body temperatures, which potentially may cause the user or caregiver of the user to delay or forego seeking appropriate care (generally an over-the-counter fever reduction medication) or receive more care than appropriate, when relying solely on the temperature display on the thermometer.
See the Press Release for product photos.
BACKGROUND: The Digital Temple Thermometer is a hand-held thermometer and can be identified by the DTT logo on the face. The back of the thermometer has a label with the KD-2201 designation. The slash-mark (/) is not part of the model number. The lot number may be found on the bottom of the back label, immediately after the designation “S/N:”
The Digital Temple Thermometer was distributed throughout the United States for direct sale and resale through consumer retail stores, and through consumer retail stores in Canada under the following packaging labels:
Best Choice (Value Merchandise)
RECOMMENDATION: Consumers who have a Digital Temple Thermometer should immediately stop using the device. Consumers may return the thermometer to Bestmed for a replacement thermometer.
To arrange for the return and replacement of the thermometer or to ask questions, consumers should contact the Bestmed via telephone at (877) 299-6700, facsimile at (303) 271-0163, or email at DTTRecall@bestmedusa.com, at any time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/30/2015 - Press Release - Bestmed, LLC]