Events

Rappel de Arceole C3F8 and SF6

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-01106-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-11
  • 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-01106-1
  • 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
    There is a possibility that 2 units of c3f8 (lot 15052502) have been incorrectly packaged in sf6 boxes. the product codes for these items are as-c3f8 and as-sf6 respectively. however, the box label, the blister label, the patient labels and the canister would be properly labelled as c3f8. there is a remote risk that the user may not identify the mislabelling before use, and incorrectly use the c3f8 gas at a concentration usually used for the sf6, which would be a maximum of 20% instead of 12%.
  • Action
    Sponsor to notify potentially affected customers. Customers to inspect and return affected sotck. Sponsor to replace affected stock. This action has been closed-out on 24/08/2016.

Device

Arceole C3F8 and SF6

Manufacturer

Device Technologies Australia Pty Ltd