Events

Rappel de Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm

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

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-2016-RN-00370-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-14
  • 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-2016-RN-00370-1
  • 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
    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.
  • Action
    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.

Device

Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm
  • Modèle / numéro de série
    Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cmBatch number 15051Expiry Date: 31 June 2020ARTG number: 201258
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare