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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Temple Thermometer

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  Class 2 Device Recall Digital Temple Thermometer see related information
Date Initiated by Firm November 12, 2015
Date Posted December 16, 2015
Recall Status1 Terminated 3 on November 30, 2016
Recall Number Z-0412-2016
Recall Event ID 72686
510(K)Number K103617  
Product Classification Thermometer, electronic, clinical - Product Code FLL
Product Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet.

Product Usage:
Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.
Code Information Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715"
Recalling Firm/
Manufacturer		 Bestmed, LLC
331 Corporate Cirle Unit E
Golden CO 80401
For Additional Information Contact Alex Burney
303-271-0300 Ext. 113
Manufacturer Reason
for Recall		 An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.
FDA Determined
Cause 2		 Process control
Action Consignees were notified verbally about 11/12/15. Written notification is planed and will include instructions on the identification of the Affected Device, potential health risk, method for return, and manner of restitution for the cost of the Affected Device.
Quantity in Commerce 305,548
Distribution US Nationwide Distribution and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FLL and Original Applicant = K-JUMP HEALTH CO., LTD.
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