Events

Rappel de Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card

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-2018-RN-00118-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-2018-RN-00118-1
  • 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 become aware that an incorrect patient card may have been included in the zenith branch endovascular graft - iliac bifurcation (zbis) devices supplied between november 2017 and january 2018. the device name on the incorrect patient card is zenith p-branch and the mri image artefact radius specified on the zbis patient card is slightly different from the image artefact radius on the incorrect patient card. the patient card is the only portion of the product impacted, there is no impact on the packaged device.There have been no customer complaints received to date in regards to this issue.
  • Action
    Cook Medical is providing replacement patient cards to all affected customers.

Device

Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient Card
  • Modèle / numéro de série
    Zenith Branch Iliac Endovascular Graft (ZBIS) - Patient CardReference Part Numbers: ZBIS-12-61-41, ZBIS-12-45-41, ZBIS-12-45-58, ZBIS-12-61-58, ZBIS-10-61-58, ZBIS-10-45-41, ZBIS-10-61-41Multiple lot numbers affectedARTG Number: 138930
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd