Events

Paratherm Heater Cooler Unit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australian Blood Management Unit Trust 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-2018-RN-00646-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00646-1
  • 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
    Updated instructions for use (ifu) and cleaning guidelines for the paratherm heater cooler unit have been released.There was a safety alert communicated in april 2017 which referenced the interim cleaning and disinfecting guidelines. during the last 12 months, validation efforts have been undertaken by the manufacturer chalice medical to support the use of a hydrogen peroxide based disinfection agent. this disinfection agent has been subject to review and subsequent inclusion in the australian register of therapeutic goods (amity hp 75, artg 302115, supplied by lovell surgical supplies international as the local sponsor).
  • 조치
    Amity HP 75 is to be made commercially available in Australia in June 2018. Stock is currently being manufactured and shipped to Australia. Once available in Australia, Australian Blood Management Unit Trust will be able to facilitate supply of this disinfection agent through Lovell Surgical Supplies International.

Device

Paratherm Heater Cooler Unit

Manufacturer

Australian Blood Management Unit Trust
  • Source
    DHTGA