Events

Retiro De Equipo (Recall) de Zenostar MT Color and Zenostar MT Color Impulse products

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ivoclar Vivadent Pty Ltd.

¿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
    RC-2016-RN-00786-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-04
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00786-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has become aware that the primary packaging of the product may show leaks. as a consequence, the liquid may leak from the dropper of the bottle.Direct contact with certain substances contained in this liquid may lead to serious eye damage and/or skin irritation. if contact is made with skin, rinse with water and if irritation continues, seek medical assistance. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Ivoclar Vivadent is advising users to inspect stock and return.

Device

Zenostar MT Color and Zenostar MT Color Impulse products
  • Modelo / Serial
    Zenostar MT Color and Zenostar MT Color Impulse productsMultiple product numbers and lot numbers affected.
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd