Events

Rappel de Sapheon (Covidien) VenaSeal 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2015-RN-00376-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-06
  • 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-2015-RN-00376-1
  • 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
    There is the potential for a sterility breach of the outer packaging (pouch) material. a breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray and does not directly affect the sterility of the device componentsthis potential for a sterile breach in the outer pouch material was discovered during standard internal packaging tests. the breach in the pouch barrier may not be detectable by visual inspection of the product. medtronic has identified possible causes for the pouch damage and has taken actions to prevent distribution of product that may be affected by this issue.
  • Action
    Customers are asked to review their inventory, quarantine product, complete the customer confirmation certificate and return all unused product to Medtronic. This action ha been closed-out on 10/08/2016.

Device

Sapheon (Covidien) VenaSeal Closure System
  • Modèle / numéro de série
    Sapheon (Covidien) VenaSeal Closure SystemLot Numbers: 37399, Mnf date: 07/08/2014, Exp date: 2016-537621, Mnf date: 28/07/2014, Exp date: 2016-338407, Mnf date: 16/10/2014, Exp date: 2016-537417, Mnf date: 16/10/2014, Exp date: 2016-738756, Mnf date: 07/11/2014, Exp date: 2016-738863, Mnf date: 20/11/2014, Exp date: 2016-9ARTG Number: 194201
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia