Tuesday, December 1, 2015

New #medical #device #recall of digital temple thermometers due to inaccurate temperature readings lower than actual.

Bestmed, LLC Issues Nationwide Recall Of Digital Temple Thermometer (DTT™), Model No. KD-2201 Manufactured By K-Jump Health Co., Ltd.

Consumers: Bestmed
(877) 299-6700
Fax: (303) 271-0163
On November 12, 2015, 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.

Consumers who have a Digital Temple Thermometer should immediately stop using the device. Consumers may return the thermometer to Bestmed for a replacement thermometer.

The following model number(s) have been recalled:

(Note: Model KD-2201L is not subject to this recall action)

The Digital Temple Thermometer is a hand-held thermometer and can be identified by the DTT™ logo on the face, as shown below:

The back of the thermometer has a label with the KD-2201 designation as shown below. 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:”. In the picture below, the lot number is S/N: 3113.

Bestmed voluntarily initiated the recall after becoming aware of the inaccurate temperature readings by the Digital Temple Thermometer, and confirming the source of the performance problem with the manufacturer, K-Jump Health Co., Ltd.

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:

Good Neighbor
Premier Value
Life Brand
Top Care
Best Choice (Value Merchandise)
Western Family
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. Our office is available Monday through Friday 9:00 AM to 7:30 PM, Eastern Time to speak with a consumer support specialist, and all messages and email will be responded to promptly.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

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