Events

Retiro De Equipo (Recall) de Germ Terminator Toothbrush Steam Sterilization

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ceg Enterprises Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    74015
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2047-2016
  • Fecha de inicio del evento
    2016-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145923
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Unit, ultraviolet sanitation/sterilization (for toothbrushes), sterile - Product Code MCF
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Model GT100
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution through Tuesday Morning retail stores.
  • Descripción del producto
    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
  • Dirección del fabricante
    Ceg Enterprises Llc, 8096 Excelsior Blvd, Hopkins MN 55343-3415
  • Source
    USFDA