Events

Rappel de Level 1 Fast Flow Fluid Warmers with and without Air Detection

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-00091-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-31
  • 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-00091-2
  • 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
    A limited number of fluid warmers were manufactured with an incorrect printed circuit board component which could prevent the fluid warmer from functioning as intended and also potentially exhibiting a false over temperature alarm.
  • Action
    Smiths Medical Australasia is requesting users to identify any affected units and place in quarantine. A Biomedical Technician will inspect devices to determine if they are affected and provide a correction.

Device

Level 1 Fast Flow Fluid Warmers with and without Air Detection
  • Modèle / numéro de série
    Level 1 Fast Flow Fluid Warmers with and without Air Detection Item Code: H-1200Affected Serial Numbers: S103A00028, S103A00029, S103A00094 and S103A00095ARTG Number: 108420
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd