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.
Recall
- Recall Number
- Z-0412-2016
- Event Number
- 72686
- Firm
- Bestmed, LLC 331 Corporate Cirle Unit E
- FEI Number
- 3003029075
- Product Code
- FLL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 12, 2015
- Posted
- December 16, 2015
- Terminated
- November 30, 2016
- Address
- Golden, CO, 80401
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.
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.
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.
US Nationwide Distribution and the country of Canada.
305,548