Z-0412-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2015
- Initiation Date
- November 12, 2015
- Termination Date
- November 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 305,548
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution and the country of Canada.
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"