Events

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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Helena Laboratories Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-00233-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00233-1
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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...
  • 모델명 / 제조번호(시리얼번호)
    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