Events

Rappel de Stryker Laparoscopic Manual Instruments and Accessories

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-01264-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-04
  • 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-01264-1
  • 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 identified that unacceptable validation reports were in place to support the unwrapped 10 minute, 132° (270°f) gravity steam sterilization cycle as well as the ethylene oxide (eo) sterilization cycle listed in instructions for use. this may give rise to cross infection as viable bacteria/ pathogens could be delivered to the subsequent patient. as a result the instructions for use (ifu) are being modified in a manner that these two sterilisation methods are being deleted and the remaining two options currently given (gravity wrapped & pre-vacuum wrapped methods) will remain in place.
  • Action
    The Gravity Unwrapped sterilization cycle and the Ethylene Oxide sterilization cycle have both been deleted as sterilisation options from the Instructions for Use (IFU1000-401-070), for Laparoscopic Instruments and Accessories. New instructions for use reflecting this deletion will be circulated to customers.The Gravity Wrapped and Pre-Vacuum Wrapped sterilisation methods will remain unchanged. This ation has been closed-out on 06/07/2016.

Device

Stryker Laparoscopic Manual Instruments and Accessories
  • Modèle / numéro de série
    Stryker Laparoscopic Manual Instruments and AccessoriesMultiple item numbers/ product descriptionsAll lotsARTG Numbers: 145845, 228398, 141250, 142780, 228395
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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