Events

Retiro De Equipo (Recall) de CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConMed Linvatec Australia 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-00844-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-24
  • 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-00844-1
  • 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
    Conmed have identified that certain core suction irrigation product have creases in the packaging seal which sometimes can result in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as result of this issue.
  • Acción
    CONMED Australia is advising users to discontinue use of the affected product and return it to ConMed for credit or replacement with unaffected product. This action has been closed-out on 17/02/2017.

Device

CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscop...
  • Modelo / Serial
    CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)Reference Numbers: CD8185, CD8190, CD8302Lot Numbers: 110609X to 20160308XManufactured between 9 June 2011 and 8 March 2016ARTG Number: 131326
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd