Events

translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 Lifetech Scientific (Shenzhen) Co., Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 137 10 18 000
  • 사례 시작날짜
    2018-10-24
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13392
  • 비고 / 경고
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • 데이터 추가 비고
    Report Source: BfArM
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Lifetech states that the size of the loader of the above systems may be too small, potentially causing difficulty for the matching delivery cable to pass through. lifetech also states that this problem can be noticed during pre-operative preparation, and that potential hazards include a delay in procedure and the need to replace the loader. lifetech further states that this problem occurs because the inner diameter of the loader did not reach its lower limit, which was caused by the manufacturing process problem of the supplier.

Device

Cera Vascular Plug Systems
  • 모델명 / 제조번호(시리얼번호)
    LT-PLUG-04 1721010410180107211801070372, 1721010410180107211801070373, 1721010410180107211801070374, 1721010410180107211801070375, 1721010410180107211801070376, 172101041018010721801070377 180107 LT-PLUG-04 1721011810180134211801340251, 172101181018013421801340252, 1721011810180134211801340253, 1721011810180134211801340254, 1721011810180134211801340255, 1721011810180134211801340256, 1721011810180134211801340258, 1721011810180134211801340259, 1721011810180134211801340260 180134 LT-PLUG-06 1720122710171252211712521320, 1720122710171252211712521321, 1720122710171252211712521322, 1720122710171252211712521323, 1720122710171252211712521327, 1720122710171252211712521328, 1720122710171252211712521329, 1720122710171252211712521330 171252 LT-PLUG-06 1721010410180107211801070384, 1721010410180107211801070385, 1721010410180107211801070386, 1721010410180107211801070387, 1721010410180107211801070388, 1721010410180107211801070389 180107 LT-PLUG-06 1721012410180146211801460777, 1721012410180146211801460778, 1721012410180146211801460779 180146 LT-PLUG-06 1720122710171252211712521325, 1720122710171252211712521324 171252 LT-PLUG-06 1721012410180146211801460780, 172101241018014621801460781 180146
  • 제품 설명
    Vascular Closure Devices
  • Manufacturer
    Lifetech Scientific (Shenzhen) Co., Ltd.

Manufacturer

Lifetech Scientific (Shenzhen) Co., Ltd.