Events

Sangofix set with hand pump (Blood/Solution Transfusion 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-2016-RN-00185-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00185-1
  • 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
    This recall is initiated due to incorrect information provided on the labelling. in the course of routine quality tests, it was discovered that sangofix sets with hand pump contain dehp (approx. 1.6% per set). the sangofix sets, however, are labelled dehp-free.The mislabelling is limited to the affected article numbers as the dehp containing hand-pumps are only used in the specified products.
  • 조치
    B. Braun is advising users to inspect stock and quarantine all units with the affected article codes. Affected stock can be returned to B. Braun and users will be issued a credit note. This action has been closed-out on 15/05/2017.

Device

Sangofix set with hand pump (Blood/Solution Transfusion Set)
  • 모델명 / 제조번호(시리얼번호)
    Sangofix set with hand pump (Blood/Solution Transfusion Set)Article Codes: 4050192, 4050192H and 4050193All Batch Numbers affectedARTG Number: 137615
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd