Recall Z-0412-2016
Bestmed, LLC · initiated November 12, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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"
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: Process control
Action taken
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.
Details
- Recall number
- Z-0412-2016
- Initiated
- November 12, 2015
- Posted by FDA
- December 16, 2015
- Terminated
- November 30, 2016
- Product code
- FLL – Continuous Measurement Thermometer
- Quantity
- 305,548
- Distribution
- US Nationwide Distribution and the country of Canada.
- Recalling firm
- Bestmed, LLC, Golden, CO