Events

Rappel de HS66 Turbo LTSF Steriliser

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-00908-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-18
  • 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-00908-1
  • 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 problem identified indicates a leakage at a critical valve due to clogging of solidified formalin solution, also known as paraformaldehyde. this leakage might affect the efficacy of the ltsf sterilisation cycle and cause potential non-sterility. the problem appears stealthy until clogging has reached the level where the built-in leakage monitoring system of the steriliser is able to indicate leakage and cause an alarm. the potential risk caused by clogging is that sterile filtered air can be introduced into the sterilizer chamber during the sterilization cycle and may partially block penetration of formaldehyde at items subjected to sterilization. the risk for non-sterility is assessed to increase at hollow instruments compared to solid instruments.
  • Action
    A Getinge representative will schedule a service technician visit to inspect, clean and take preventive measures at your sterilizer for the problem not to reappear. In the meantime all users are advised to take precautions as follows: - Depending of the occurrence and frequency of LTSF sterilization at your sterilization department use biological indicators for monitoring the sterilization efficacy at a daily or weekly basis; - When growth is indicated by biological indicators - stop using the sterilizer and contact your Getinge representative for prompt assistance. This action has been closed-out on 03/06/2016.

Device

HS66 Turbo LTSF Steriliser

Manufacturer

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