Events

Rappel de OXYGEN Sterile Protection

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Danex Medical 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-2014-RN-00904-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-18
  • 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-2014-RN-00904-1
  • 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
    In a limited number of the product, oxygen sterile protection (pn: 60200), a protective cover foil that protects the transparent part of the lens hood system is not removed at some pieces. independent testing undertaken by the manufacturer has indicated that sterility of the product may not be breached despite the presence of protective cover foil,.
  • Action
    Hospitals were advised that if they find any products with the green film still attached to the visor to put it aside and Danex Medical Pty Ltd will collect and replace the lens hoods at no charge. This action was undertaken prior to the notification to the TGA. This action has been closed-out on 11/11/2016.

Device

OXYGEN Sterile Protection
  • Modèle / numéro de série
    OXYGEN Sterile Protection Part Number: 60200Lot/batch No.: 201401
  • Manufacturer
    Danex Medical Pty Ltd

Manufacturer

Danex Medical Pty Ltd