Events

Recall of Device Recall Digital Temple Thermometer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bestmed, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72686
  • Event Risk Class
    Class 2
  • Event Number
    Z-0412-2016
  • Event Initiated Date
    2015-11-12
  • Event Date Posted
    2015-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141980
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermometer, electronic, clinical - Product Code FLL
  • 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.
  • 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.

Device

Device Recall Digital Temple Thermometer
  • Model / Serial
    Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715"
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution and the country of Canada.
  • 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.
  • Manufacturer
    Bestmed, LLC

Manufacturer

Bestmed, LLC
  • Manufacturer Address
    Bestmed, LLC, 331 Corporate Cirle Unit E, Golden CO 80401
  • Source
    USFDA