Events

Cook LapSac Surgical Tissue Pouch 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-00500-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00500-1
  • 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
    Updates to the ifu are being made to discourage use of laparoscopic power morcellation in cases where the presence of cancerous tissue cannot be ruled out. the intended use for the device is being modified from "used to isolate tissue during, or prior to, surgical removal and or morcellation" to "used to isolate tissue during, or prior to surgical removal". a contraindication i.E., 'not for use with power morcellators' is also being added to the ifu. additionally, warnings and instructions in the ifu is being updated.
  • 조치
    Customers are advised to pass the customer letter on to appropriate personnel within their organisation or to any organisation where the potentially affected devices have been transferred. This action has been closed-out on 26/08/2016.

Device

Cook LapSac Surgical Tissue Pouch

Manufacturer

William A Cook Australia Pty Ltd