Events

Rappel de 12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)

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-00480-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-29
  • 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-00480-1
  • 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 has become aware that gravity sterilisation parameters provided in the 12 instrument sterilisation reprocessing guide (1000400920 rev d) did not fully consider all worst-case scenarios during validation testing. although, to date there have been no reported events to stryker of infection as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection.
  • Action
    End users are advised to discard any old Instructions for Use (IFU) for 12 Instrument Sterilization Tray(s) that make reference to the gravity steam sterilization method (121oC for 30 minutes). New IFU can be downloaded from www.stryker.com/12instrumenttray

Device

12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)
  • Modèle / numéro de série
    12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)Catalogue Number: 0242000012All lots shipped from manufacturer between January 10, 2008 and January 10, 2014 ARTG Number: 140639
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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