Retiro De Equipo (Recall) de Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm

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

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 device is typically used to protect wounds and arrest bleeding in an emergency situation. it consists of a pad attached to a roll bandage. the pad is applied directly to the wound and the bandage is subsequently wrapped around the pad. a pressure bar mechanism provides pressure to the wound site. it has been reported that the pressure bar material from a specific batch has inadequate strength and may break during use.
  • Acción
    Aero Healthcare is advising customers to inspect stocks and quarantine the affected units prior to their return. This action has been closed-out on 26/05/2017.


  • Modelo / Serial
    Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cmBatch number 15051Expiry Date: 31 June 2020ARTG number: 201258
  • Manufacturer