Events

Rappel de Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Actelion Pharmaceuticals 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-2016-RN-00147-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-09
  • 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-00147-1
  • 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
    Complaints have been received regarding leakage and under-filling of ecoflac plus bottles with cracks at the transition from the container shoulder to the container body. this may result in microbial contamination of the product and pose a risk to patients.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected kits prior to their return. Until replacement kit is received, patients are recommended to use an alternative unaffected water for injection product. If this is not available, patients should check each bottle of water carefully before use to ensure the container and its closure or packaging are undamaged. DO NOT use the bottle if a leak has been noticed. This action has been closed-out on 03/02/2017.

Device

Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections
  • Modèle / numéro de série
    Veletri Consumables Kit - Infusion administration set containing B. Braun Water for Injections Lot Number: 14217404 (B. Braun Water for Injections)Batch numbers: 0309757 and 0309991 (Veletri Consumables Kit)Expiry Date: 2017-04ARTG Number: 219458
  • Manufacturer
    Actelion Pharmaceuticals Australia Pty Ltd

Manufacturer

Actelion Pharmaceuticals Australia Pty Ltd