Events

SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun 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-2013-RN-01289-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01289-1
  • 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
    Following reports of leaking from the in-line safsite injection site, initial investigations have identified that on disconnection of a luer connector used to access the injection site, a resealing issue may occur intermittently. this may result in fluid leaking from the valve.
  • 조치
    As an interim corrective action, B.Braun is recommending that end users fit a stand-alone Safsite valve to the in-line injection site. The valve can be used for injection or infusion and does not need to be removed. Further notifications will be undertaken if any additional actions are required based on B. Braun's investigations.

Device

SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set
  • 모델명 / 제조번호(시리얼번호)
    SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration SetArticle code: 4050193Batch number: 3H24278T34ARTG Number: 137615HEIDELBERG EXTENSION TUBINGArticle code: 4052197 Batch number: 3H21278A23ARTG Number:139265
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd