Events

Laparascopic inserts with tube, 3.00mm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-2013-RN-01307-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01307-1
  • 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
    The manufacturer has identified a potential risk with the affected laparascopic inserts where during reprocessing, the inner lumen of these laparascopic inserts cannot be flushed out sufficiently with the recommended rising tip. further investigation showed that all inserts, which cannot be disassembled are affected, and that this it could lead to infection.
  • 조치
    The affected laparoscopic instruments have not been used and are in their original packaging. Life Healthcare is advising users to return the affected laparoscopic instruments for replacement stock .

Device

Laparascopic inserts with tube, 3.00mm
  • 모델명 / 제조번호(시리얼번호)
    Laparascopic inserts with tube, 3.00mmItem Numbers: RS-003-316, RS-003-325, RS-003-390Lot Numbers: 13J028#06102952, 13J028#06082301, 06082129/28,08ARTG Number: 141681
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd