Events

Rappel de Safe-T-Vue 6 and Safe-T-Vue10 Temperature Indicators (used to monitor the temperature of blood bags during transit)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Helena Laboratories 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-2016-RN-00233-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • 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-2016-RN-00233-1
  • 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 manufacturer, temptime is making a change to safe-t-vue’s instructions for use. the instructions on the box and package insert state that indicators must be removed from refrigeration and brought to room temperature every 3 months. temptime conducted additional testing and determined that safe-t-vue indicators must be removed from refrigeration for 24 to 48 hours every 2 months. storing safe-t-vue in refrigerated conditions for greater than 2 months may lead to failure of the indicator to change colour when the specified temperature has been reached.
  • Action
    Helena Laboratories is providing updated Instructions For Use (IFU) for users to follow.

Device

Safe-T-Vue 6 and Safe-T-Vue10 Temperature Indicators (used to monitor the temperature of blood ba...
  • Modèle / numéro de série
    Safe-T-Vue 6 and Safe-T-Vue10 Temperature Indicators (used to monitor the temperature of blood bags during transit)Multiple part numbers and lot numbers affectedARTG Number: 265484
  • Manufacturer
    Helena Laboratories Australia Pty Ltd

Manufacturer

Helena Laboratories Australia Pty Ltd