Events

Retiro De Equipo (Recall) de OXYGEN Sterile Protection

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Danex Medical 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-00904-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-18
  • 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-00904-1
  • 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
    In a limited number of the product, oxygen sterile protection (pn: 60200), a protective cover foil that protects the transparent part of the lens hood system is not removed at some pieces. independent testing undertaken by the manufacturer has indicated that sterility of the product may not be breached despite the presence of protective cover foil,.
  • Acción
    Hospitals were advised that if they find any products with the green film still attached to the visor to put it aside and Danex Medical Pty Ltd will collect and replace the lens hoods at no charge. This action was undertaken prior to the notification to the TGA. This action has been closed-out on 11/11/2016.

Device

OXYGEN Sterile Protection
  • Modelo / Serial
    OXYGEN Sterile Protection Part Number: 60200Lot/batch No.: 201401
  • Manufacturer
    Danex Medical Pty Ltd

Manufacturer

Danex Medical Pty Ltd