Events

Zenostar MT Color and Zenostar MT Color Impulse products 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ivoclar Vivadent 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-00786-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00786-1
  • 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 manufacturer has become aware that the primary packaging of the product may show leaks. as a consequence, the liquid may leak from the dropper of the bottle.Direct contact with certain substances contained in this liquid may lead to serious eye damage and/or skin irritation. if contact is made with skin, rinse with water and if irritation continues, seek medical assistance. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Ivoclar Vivadent is advising users to inspect stock and return.

Device

Zenostar MT Color and Zenostar MT Color Impulse products
  • 모델명 / 제조번호(시리얼번호)
    Zenostar MT Color and Zenostar MT Color Impulse productsMultiple product numbers and lot numbers affected.
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd