Events

Counterfeit Durex branded condoms purchased from Groupon website 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Groupon 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-00346-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-04-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00346-1
  • 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 durex branded condoms sold by edgelounge enterprises pty ltd (trading as citrus beat) on groupon australia's website between 12.03.2015 to 10.04.2015 are counterfeit goods with defects such as holes in the latex and they may fail.
  • 조치
    Groupon Australia is informing the customers not to use these condoms and destroy or dispose them or return them for a full refund. For more information, please see the TGA web statement published at http://www.tga.gov.au/alert/counterfeit-durex-branded-condoms-purchased-groupon-website . This action has been closed-out on 19/10/2016.

Device

Counterfeit Durex branded condoms purchased from Groupon website
  • 모델명 / 제조번호(시리얼번호)
    Counterfeit Durex branded condoms purchased from Groupon websiteSold between 12.03.2015 to 10.04.2015.
  • Manufacturer
    Groupon Australia Pty Ltd

Manufacturer

Groupon Australia Pty Ltd