Events

Retiro De Equipo (Recall) de Gluma Desensitizer Power Gel

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 Heraeus Kulzer, 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
    68223
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1651-2014
  • Fecha de inicio del evento
    2014-04-23
  • Fecha de publicación del evento
    2014-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127168
  • 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
    Varnish, cavity - Product Code LBH
  • Causa
    The firm discovered that the gluma desensitizer power gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. if extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. this would cause irritation, burning or blistering.
  • Acción
    Heraeus Kulzer sent a Voluntary Recall letter dated April 22, 2014 to all affected doctors and supply centers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Inspect your inventory, both in storage and in use, and identify the lot number on your kits and syringes. Refer to attached images. 2. If you identify any Gluma Desensitizer PowerGel with the aforementioned kit or syringe lot numbers, immediately cease usage of this product and call Technical Services at 1 (574) 299-5409 3. Please advise if you forwarded this product to any other end users. We will need their contact information inClusive of name, address and phone number. For questions regarding this notification, please call our Technical Service team at (574) 299-5409.

Device

Gluma Desensitizer Power Gel
  • Modelo / Serial
    Model Number(s): 66043451 Expiry: 2015-09 Syringe Lot number 010103, which are contained within Kit lot numbers 42.43.44.45.46.47.48.49,50, and 51.   Note; lots 49 and 50 were captured in house, 0 was distributed. Lot 51 was made by the manufacturer, however, never received by us or distributed.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,
  • Descripción del producto
    Gluma Desensitizer Power Gel || Product Usage: Usage: || This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.
  • Manufacturer
    Heraeus Kulzer, LLC.

Manufacturer

Heraeus Kulzer, LLC.
  • Dirección del fabricante
    Heraeus Kulzer, LLC., 300 Heraeus Dr, South Bend IN 46614-2557
  • Empresa matriz del fabricante (2017)
    Mitsui Chemicals Inc.
  • Source
    USFDA