Events

HOTLINE Fluid Warming Sets 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smiths Medical Australasia 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-2014-RN-00344-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00344-1
  • 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
    Smiths medical has become aware of an issue with a limited number of warming sets with the potential for leakage form the injection port at the top of the warming set. if fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the warming set and obtain a replacement. this could present a minor delay in therapy while a replacement warming set is obtained.
  • 조치
    Smiths Medical is requesting their customers to segregate all affected units. Upon confirmation of the location of affected units a service representative will arrange for the exchange of unused warming sets. This action has been closed-out on 31/08/2016.

Device

HOTLINE Fluid Warming Sets
  • 모델명 / 제조번호(시리얼번호)
    HOTLINE Fluid Warming SetsProduct Codes: L-70 and L-80Multiple lot numbers affected ARTG Number: 99436
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd