Events

Rappel de TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook 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-00795-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-18
  • 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-00795-1
  • 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
    Cook medical has received complaints that some tri-ex extraction balloons may not fit through endoscopes with a 2.8 mm channel. the extraction balloon is labelled for use with a 2.8 mm endoscope.
  • Action
    Cook medical is requesting their customers to review their stock for the affected lot numbers and quarantine any affected product in preparation for return. This action has been closed-out on 03/06/2016.

Device

TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only)
  • Modèle / numéro de série
    TXR-ME (Tri-Ex Extraction Balloon with Multiple Sizing)(275 cm Length only) Serial Numbers: W3372236(1), W3376524(1), W3427509(2), W3406080(1), W3388883(2), W3403192(2), W3334395(1), W3374821(1), W3376524(1), W3308765(2), W3333058(2), W3415262(2)ARTG number: 133685
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd