Events

Retiro De Equipo (Recall) de ArthroCare Corporation HipVac 50 Coblation Wand

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Arthrocare Australasia 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-2014-RN-01203-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-12
  • 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-2014-RN-01203-1
  • 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
    Based on internal investigation, arthrocare has confirmed that the packaging tray that houses the hipvac wand may have been damaged, which could result in a breach of the sterile barrier. this failure was discovered during final inspection.
  • Acción
    Customers are requested to Immediately discontinue use of the HipVac Wand immediately and take steps to quarantine the devices. If affected product is identified, Smith & Nephew Surgical Customer Service will be in contact with customers once the disposition form is returned, to arrange for the product to be returned and suggest alternate products. This action has been closed-out on 06/07/2016.

Device

ArthroCare Corporation HipVac 50 Coblation Wand
  • Modelo / Serial
    ArthroCare Corporation HipVac 50 Coblation WandModel Number: ASHA4730-01ARTG number: 221504
  • Manufacturer
    Arthrocare Australasia Pty Ltd

Manufacturer

Arthrocare Australasia Pty Ltd