Events

Rappel de 5mm ENDOPATH XCEL Trocars with Optiview Technology

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2018-RN-00284-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-05
  • 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-2018-RN-00284-1
  • 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
    Johnson & johnson medical has been advised that the manufacturer, ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm endopath xcel trocars with optiview technology.To date, no injuries have been reported as a result of this issue.
  • Action
    Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.

Device

5mm ENDOPATH XCEL Trocars with Optiview Technology
  • Modèle / numéro de série
    5mm ENDOPATH XCEL Trocars with Optiview TechnologyBladeless 5x100 StabilityProduct Code 2B5LTBatch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004GBladeless 5X75 StabilityProduct Code 2B5STBatch Numbers: P4T745, P4T906, P4T91HSleeve 5x100 StabilityProduct Code 2CB5LTBatch Numbers: P4T636, P4T63G, P4T708, P4T89NSleeve 5x75 StabilityProduct Code 2CB5STBatch Numbers: P4T686, P4T99K,P4T79AExpiry: between Sep 2022 - Jan 2023ARTG: 108472, 108482
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd