Events

Rappel de Germ Terminator Toothbrush Steam Sterilization

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ceg Enterprises Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74015
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2047-2016
  • Date de mise en oeuvre de l'événement
    2016-04-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145923
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile - Product Code MCF
  • Cause
    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
  • Modèle / numéro de série
    Model GT100
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution through Tuesday Morning retail stores.
  • Description du dispositif
    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
  • Adresse du fabricant
    Ceg Enterprises Llc, 8096 Excelsior Blvd, Hopkins MN 55343-3415
  • Source
    USFDA