5mm ENDOPATH XCEL Trocars with Optiview Technology 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2018-RN-00284-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-05
  • 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
    Johnson & johnson medical has been advised that the manufacturer, ethicon, has become aware of reports from customers related to difficulty removing the obturator from the 5mm endopath xcel trocars with optiview technology.To date, no injuries have been reported as a result of this issue.
  • 조치
    Johnson & Johnson Medical is advising users to inspect stock for affected product. Users should complete the Response Form provided with the Customer Letter to arrange for return and replacement of affected goods.

Device

  • 모델명 / 제조번호(시리얼번호)
    5mm ENDOPATH XCEL Trocars with Optiview TechnologyBladeless 5x100 StabilityProduct Code 2B5LTBatch Numbers: P4T58Y, P4T665, P4T83K, P4T88G, P4T927, R4000W, R4004GBladeless 5X75 StabilityProduct Code 2B5STBatch Numbers: P4T745, P4T906, P4T91HSleeve 5x100 StabilityProduct Code 2CB5LTBatch Numbers: P4T636, P4T63G, P4T708, P4T89NSleeve 5x75 StabilityProduct Code 2CB5STBatch Numbers: P4T686, P4T99K,P4T79AExpiry: between Sep 2022 - Jan 2023ARTG: 108472, 108482
  • Manufacturer

Manufacturer