Events

Rappel de Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gambro 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-2013-RN-00086-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-01
  • 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-2013-RN-00086-2
  • 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
    Gambro has identified a potential for increased likelihood of clotting following the introduction of the new venous chamber on conventional bloodlines which are used with the integra and ak machines. the new venous chamber design may increase the likelihood of clotting due to the presence of potentially stagnant areas beside the blood flow inlet.
  • Action
    Gambro is providing additional instructions for use for the correct blood level setting in the venous chamber. In addition, Gambro will discontinue the new design and re-introduce the original design.

Device

Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tub...
  • Modèle / numéro de série
    Gambro Conventional Bloodlines; BL200 BD Pre Post, BL208 BD & BL223PB (dialysis/haemodialysis tubing set)BL200 BD Pre Post;Product Code 114635, Batch Numbers from 1240 to 1303BL208BD;Product Code:114557Batch numbers from 1242 to 1304BL223 PB;Product Code: 114636Batch Numbers from 1252ARTG Number: 141589
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd