Events

Rappel de Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management 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 Stryker 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-2014-RN-00139-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-11
  • 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-00139-1
  • 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
    Stryker is implementing upgrades to the neptune 2 waste management system further to the previous recall for product correction in may 2013 (tga reference: rc-2013-rn-00265-1) where stryker received reports of serious injury or death in the usa due to the neptune 2 being connected to a passive chest drainage tube or closed wound drainage device post-operatively.
  • Action
    Stryker is upgrading the Neptune 2 Rover Ultra units with a new top cap, labels and software package to mitigate the potential for incorrect use. Thia action has been closed-out on 28/01/2016.

Device

Neptune 2 Rover Ultra (Mobile unit used as surgical fluid/smoke waste management system)

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA