Events

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

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Helena Laboratories Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00233-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-01
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00233-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / 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