Events

CompoStop Flex 3F T&B; - 100/600/1300 - PLT Pooling - processing and leuko reduction system (Blood donor set) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fresenius Kabi Australia Pty Limited 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-01329-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01329-1
  • 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
    Fresenius kabi has decided to take this precautionary action due to possible leakage at the welding, near the position of the twist off connector. as such, the sterility may be compromised.
  • 조치
    Fresenius Kabi is requesting their customers to discontinue use of batch 40GH28GA00 including any blood components stored in the products. Units from the affected batch are required to be returned to Fresenius Kabi.

Device

CompoStop Flex 3F T&B; - 100/600/1300 - PLT Pooling - processing and leuko reduction system (Bloo...
  • 모델명 / 제조번호(시리얼번호)
    CompoStop Flex 3F T&B; - 100/600/1300 - PLT Pooling - processing and leuko reduction system (Blood donor set)Article Code: T5000Batch 40GH28GA00ARTG Number: 149450
  • Manufacturer
    Fresenius Kabi Australia Pty Limited

Manufacturer

Fresenius Kabi Australia Pty Limited