Events

Arceole C3F8 and SF6 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2015-RN-01106-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01106-1
  • 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
    There is a possibility that 2 units of c3f8 (lot 15052502) have been incorrectly packaged in sf6 boxes. the product codes for these items are as-c3f8 and as-sf6 respectively. however, the box label, the blister label, the patient labels and the canister would be properly labelled as c3f8. there is a remote risk that the user may not identify the mislabelling before use, and incorrectly use the c3f8 gas at a concentration usually used for the sf6, which would be a maximum of 20% instead of 12%.
  • 조치
    Sponsor to notify potentially affected customers. Customers to inspect and return affected sotck. Sponsor to replace affected stock. This action has been closed-out on 24/08/2016.

Device

Arceole C3F8 and SF6
  • 모델명 / 제조번호(시리얼번호)
    Arceole C3F8 and SF6 Lot Number: 15052502Product Codes: AS-C3F8 and AS-SF6. ARTG Number: 233561
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd