Events

Retiro De Equipo (Recall) de Fluoron Gas Tamponade EasyGas SF6

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

¿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-01327-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-18
  • 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-01327-1
  • 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
    Fluoron gmbh is voluntarily recalling the product due to a potential incorrect bottling of the longer acting gas c3f8 (12%) instead of sf6 (20%).
  • Acción
    IQ Medical is requesting surgeons/healthcare professionals to notify their patients who received the affected products about the resulting extended prohibition of flying, diving and anaesthesia using nitrous oxide of 60 days from treatment. IQ Medical is also recalling any remaining stock in the market. This action has been closed-out on 08/03/2016.

Device

Fluoron Gas Tamponade EasyGas SF6
  • Modelo / Serial
    Fluoron Gas Tamponade EasyGas SF6Item Number: G-80950Lot Numbers: EG1 300614 and EG1 150714ARTG Number: 197089
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical