Events

Macopharma blood bags 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 MacoPharma 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-00994-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00994-1
  • 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
    Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (bat) systems.The slits cut into the cv1014 pack are used to store the crossmatch line ‘pig-tails’. the hanging loop is used during the inversion of the pack to run additive into the concentrate red cells. this recall action was undertaken prior to consultation with the tga.
  • 조치
    Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016.

Device

Macopharma blood bags
  • 모델명 / 제조번호(시리얼번호)
    Macopharma blood bagsProduct Code: LQT6283LBMultiple batches affectedARTG Number: 142856
  • Manufacturer
    MacoPharma Australia Pty Ltd

Manufacturer

MacoPharma Australia Pty Ltd