Events

Rappel de A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wing

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Terumo 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-01147-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-20
  • 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-01147-1
  • 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
    Kawasumi laboratories inc. in japan has received 4 reports worldwide where the needle cannula of the a.V fistula set for haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • Action
    Terumo advises users to stop using the A.V Fistula set for Haemodialysis from the affected population. Customers are advised to quarantine and destroy all product in the affected population. This action has been closed-out on 31/08/2016.

Device

A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wing
  • Modèle / numéro de série
    A.V. Fistula sets for Haemodialysis - Safety AVF Needle fixed wingCatalogue Numbers: AVFE1525CLFG and AVFE1525CPLFGLot Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1, 140912I6, 141110I2ARTG Number: 121471
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd