Events

Rappel de Ambu AuraGain Single Use Laryngeal Mask – Sterile

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par AMBU Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-01240-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01240-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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

Ambu AuraGain Single Use Laryngeal Mask – Sterile
  • Modèle / numéro de série
    Ambu AuraGain Single Use Laryngeal Mask – SterileVarious Lot Numbers affectedARTG Number: 220597
  • Manufacturer
    AMBU Australia Pty Ltd

Manufacturer

AMBU Australia Pty Ltd