Recall Z-0412-2016 ยท FLL Continuous Measurement Thermometer
Bestmed, LLC
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
| Date | Dec 16, 2015 (initiated Nov 12, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 305,548 |
| Distribution | US Nationwide Distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103617 | DIGITAL FOREHEAD THERMOMETER K-Jump Health Co., Ltd., Apr 4, 2011 |