Events

Recall of Germ Terminator Toothbrush Steam Sterilization

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ceg Enterprises 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
    74015
  • Event Risk Class
    Class 2
  • Event Number
    Z-2047-2016
  • Event Initiated Date
    2016-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145923
  • 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
    Unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile - Product Code MCF
  • Reason
    Ceg enterprises, llc is recalling germ terminator toothbrush sanitizer gt100 due to the following issues: ul label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.
  • Action
    CEG Enterprises sent an Urgent Germ Terminator Toothbrush Sanitizer GT100 Recall letter dated April 19, 2016, via UPS and email to all affected customers. The letter identified the affected product, the reason for recall, stated to quarantine product, and to return all remaining product. The letter also instructed that Tuesday Morning retail stores post the recall notification letter on the retail shelves where the product was offered for sale, as well as on their website. Consumers are encouraged to return the device to a Tuesday Morning retail store. Questions can be directed to 612-337-1821

Device

Germ Terminator Toothbrush Steam Sterilization
  • Model / Serial
    Model GT100
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution through Tuesday Morning retail stores.
  • Product Description
    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
  • Manufacturer
    Ceg Enterprises Llc

Manufacturer

Ceg Enterprises Llc
  • Manufacturer Address
    Ceg Enterprises Llc, 8096 Excelsior Blvd, Hopkins MN 55343-3415
  • Source
    USFDA