Retiro De Equipo (Recall) de Ambu AuraGain Single Use Laryngeal Mask – Sterile

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por AMBU 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-2015-RN-01240-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    A failure has been discovered during routine quality control at the manufacturing site. this failure may cause a small hole (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier.It has been estimated that this failure mode occurs in 3% of the affected lots. ambu has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014.
  • Acción
    AMBU is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 31/08/2016.

Device

  • Modelo / Serial
    Ambu AuraGain Single Use Laryngeal Mask – SterileVarious Lot Numbers affectedARTG Number: 220597
  • Manufacturer

Manufacturer