Events

Rappel de CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConMed Linvatec 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-2016-RN-00844-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-24
  • 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-2016-RN-00844-1
  • 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
    Conmed have identified that certain core suction irrigation product have creases in the packaging seal which sometimes can result in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as result of this issue.
  • Action
    CONMED Australia is advising users to discontinue use of the affected product and return it to ConMed for credit or replacement with unaffected product. This action has been closed-out on 17/02/2017.

Device

CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscop...
  • Modèle / numéro de série
    CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)Reference Numbers: CD8185, CD8190, CD8302Lot Numbers: 110609X to 20160308XManufactured between 9 June 2011 and 8 March 2016ARTG Number: 131326
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd