Events

Rappel de Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2014-RN-01079-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-09
  • 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-2014-RN-01079-1
  • 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
    Integra neurosciences has identified through an investigation of complaints that some specific lots of selector® tubing kits may potentially leak irrigation fluid during use if not placed on the selector handpiece in a specific manner. if the lumens of the 2 tubes are not separated before placing them on the handpiece barbs, this could result in an irrigation fluid leak. if the leakage is significant, the handpiece tip could overheat and possibly burn tissue being treated.
  • Action
    Integra is providing additional instructions to prevent the occurrence of leakage. This action has been closed-out on 03/06/2016.

Device

Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
  • Modèle / numéro de série
    Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators Catalogue number: 1517079Multiple lot numbersARTG number: 146847
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd