Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Helena Laboratories Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00233-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00233-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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