Events

Rappel de Cavafix (used for the catheterisation of vena cava)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun 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-2014-RN-00419-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-08
  • 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-00419-1
  • 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 the course of internal quality checks the manufacturer discovered that aging of these products can result in deposits of particles on the surface of the catheters. to date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to b. braun melsungen ag.
  • Action
    B.Braun is requesting their customers to inspect their stock and quarantine any units from the affected batches. All affected stock will be recovered by B.Braun and a credit note issued. This action has been closed-out on 29/01/2016.

Device

Cavafix (used for the catheterisation of vena cava)
  • Modèle / numéro de série
    Cavafix (used for the catheterisation of vena cava)Article Code: 4152557, 4173350, 4173759 All batchesARTG Number: 142123
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd