Events

Rappel de Laparascopic inserts with tube, 3.00mm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-2013-RN-01307-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-19
  • 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-2013-RN-01307-1
  • 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
    The manufacturer has identified a potential risk with the affected laparascopic inserts where during reprocessing, the inner lumen of these laparascopic inserts cannot be flushed out sufficiently with the recommended rising tip. further investigation showed that all inserts, which cannot be disassembled are affected, and that this it could lead to infection.
  • Action
    The affected laparoscopic instruments have not been used and are in their original packaging. Life Healthcare is advising users to return the affected laparoscopic instruments for replacement stock .

Device

Laparascopic inserts with tube, 3.00mm
  • Modèle / numéro de série
    Laparascopic inserts with tube, 3.00mmItem Numbers: RS-003-316, RS-003-325, RS-003-390Lot Numbers: 13J028#06102952, 13J028#06082301, 06082129/28,08ARTG Number: 141681
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd