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.
FDA Recall Z-0412-2016 · Posted 2015-12-16
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Recalling FirmBestmed, LLC
Recall StatusTerminated
Product CodeFLL
Date Initiated2015-11-12
Date Terminated2016-11-30
Product Quantity305,548
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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