Events

Rappel de FemoSeal Vascular Closure 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 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-2017-RN-01092-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-08-22
  • 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-01092-1
  • 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
    Terumo medical corporation has received an increase in device related malfunction complaints for femoseal vascular closure systems. specifically, after the deployment of the inner locking disc, the complaints state that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure.An investigation by terumo has identified that the internal suture becomes entrapped as a result of operator miss-assembly during device manufacture and that this issue then only becoming visible midway through device deployment.
  • Action
    1. Review the urgent medical device recall notification and distribute to all staff working with this equipment. 2. Inform any facilities that may have received this product of the recall action. 3. Quarantine all product in the affected population, record the lot number and quantity on the Customer Response Form supplied with the Customer Letter 4. Place quarantined product in a secure location for return to Terumo Australia Regulatory Affairs Department. 5. Package and return all affected product via courier

Device

FemoSeal Vascular Closure System
  • Modèle / numéro de série
    FemoSeal Vascular Closure SystemAll non-expired productProduct Code: C11202Multiple Lot NumbersARTG Number: 263892
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd