Events

Rappel de Intro-Flex Automatic Hemostasis Valve Introducer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Edwards Lifesciences 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-01488-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-05
  • 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-01488-1
  • 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
    This recall involves an introducer sheath that was found to be out of specification. if the sheath inner diameter is too small, the clinician may have difficulty inserting the dilator or catheter into the introducer. this will cause a procedural delay as the clinician will need to change out the device over a guidewire with a minimal delay in treatment.There have been no injuries as a result of this issue.
  • Action
    Edwards is advising users to inspect stock and quarantine any remaining units of the affected lot. Affected units can be returned to Edwards.

Device

Intro-Flex Automatic Hemostasis Valve Introducer
  • Modèle / numéro de série
    Intro-Flex Automatic Hemostasis Valve IntroducerModel Number: I300F85Lot Number: 60377828ARTG Number: 146688
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd