Events

Anspach Attachments and Handpieces (reusable surgical devices) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2014-RN-00651-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00651-1
  • 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
    Internal testing of sterrad® 100s sterilisation process has shown that several anspach attachments and handpieces did not achieve the expected sterility assurance level (sal) of 10-6.
  • 조치
    Synthes Australia is notifying their customers of the removal of the recommendation to sterilise Anspach Attachments and Handpieces in the STERRAD 100S (Hydrogen Peroxide Gas Plasma Technology). Steam sterilisation method is still validated for the sterilisation of these devices.

Device

Anspach Attachments and Handpieces (reusable surgical devices)
  • 모델명 / 제조번호(시리얼번호)
    Anspach Attachments and Handpieces (reusable surgical devices)Multiple part numbers and lot numbersARTG Numbers: 141597, 141559, 141600, 146267 and 155913
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd