Events

Vygon SA – Y connector code 884.08(tubing connector) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-00634-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-07-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00634-1
  • 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
    Vygon has identified a manufacturing defect, which could result in blockage of the y-connector. this obstruction cannot be visually detected by the end user before use.
  • 조치
    Device Technologies are requesting users read this notice in full and distribute to all relevant personnel and to inspect their inventory and isolate any of Vygon Y Connector with product code VY-884.08 and lot number 100315EG and to complete the attached Reply Fax Form. This action has been closed-out on 31/08/2016.

Device

Vygon SA – Y connector code 884.08(tubing connector)
  • 모델명 / 제조번호(시리얼번호)
    Vygon SA – Y connector code 884.08(tubing connector)Lot Number: 100315EGARTG Number: 139853
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd