Events

Rappel de Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-01070-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-03
  • 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-01070-1
  • 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
    Baxter healthcare has received reports of leaks at the spike's air vent subassembly.A leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if not detected during priming or initial set up, this may lead to serious adverse health consequences. this leak may also result in potential skin contact which would result in potential skin irritation.
  • Action
    Baxter Healthcare is advising users to inspect and quarantine any affected stock for return to Baxter. This action has been closed-out on 31/08/2016.

Device

Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic d...
  • Modèle / numéro de série
    Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)Product Code: MMC9627SLot Number: 14H13V434ARTG Number: 108526
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd