Recall Z-0412-2016— Bestmed, LLC

Name: FDA recall Z-0412-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-12

Class II · Terminated

Class II FDA medical device recall by Bestmed, LLC, initiated 2015-11-12, terminated 2016-11-30. It names one FDA 510(k) clearance: K103617. 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.. Reason: 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..

Recalling firm: Bestmed, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-12
Terminated: 2016-11-30
Firm location: Golden, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K103617 — DIGITAL FOREHEAD THERMOMETERK-Jump Health Co., Ltd.·cleared 2011-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.