CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConMed Linvatec 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-00844-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-24
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Conmed have identified that certain core suction irrigation product have creases in the packaging seal which sometimes can result in an open channel. these channels may compromise sterility of the product. there have been no reports of injuries as result of this issue.
  • 조치
    CONMED Australia is advising users to discontinue use of the affected product and return it to ConMed for credit or replacement with unaffected product. This action has been closed-out on 17/02/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    CONMED CORE Suction Irrigation Handpieces (used to perform suction and irrigation during endoscopic procedures)Reference Numbers: CD8185, CD8190, CD8302Lot Numbers: 110609X to 20160308XManufactured between 9 June 2011 and 8 March 2016ARTG Number: 131326
  • Manufacturer

Manufacturer