Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier
FDA device recall Z-0412-2016 · posted 2015-12-16 · Terminated
Recall details
- Recalling firm
- Bestmed, LLC
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FLL
- Quantity affected
- 305,548
- Distribution
- US Nationwide Distribution and the country of Canada.
- Date initiated
- 2015-11-12
- Date posted
- 2015-12-16
- Date terminated
- 2016-11-30
- Location
- Golden, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIGITAL FOREHEAD THERMOMETER (K103617) | K-Jump Health Co., Ltd. | 2011-04-04 |