Events

Rappel de Cordis S.M.A.R.T. Flex Vascular Stent System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Cardinal Health Australia 503 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-2017-RN-01446-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-29
  • 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-2017-RN-01446-1
  • 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
    Cordis has determined that certain lots of the s.M.A.R.T. flex vascular stent system have a potential for cracked luer hubs, due to a manufacturing error.The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter. the potential medical consequence would be a delay in device preparation, resulting in the need to prepare a replacement device for use. cordis does not anticipate any other patient impact.
  • Action
    Cordis is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

Cordis S.M.A.R.T. Flex Vascular Stent System

Manufacturer

Cardinal Health Australia 503 Pty Ltd