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 Newdeal SAS 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 091 10 11 000
  • 사례 시작날짜
    2011-10-30
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=970
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    Newdeal sas has recently become aware that one batch of snap-off® screw dia. 2.7mm- length 20mm non sterile (catalog number 117 020 – batch ek79) has been etched and labeled with specifications of the snap-off® screw dia. 3.0mm length 20mm sterile (catalog number 117 120s – batch en5j). although we have not received any information showing that the use of such affected devices had significant consequence on patients, as a preventive measure, newdeal sas has made a decision to conduct a recall.

Device

SNAP-OFF SCREW
  • 모델명 / 제조번호(시리얼번호)
    Diameter:2.7 mm*length 20 mm (non sterile) Diameter:3.0 mm*length 20 mm (sterile) Model: 117 020 (non sterile) and 117 120S (sterile) Lot/batch no: EK79 (117 020) EN5J (117 020S)
  • 제품 설명
    SCREW, sterile, non sterile
  • Manufacturer
    Newdeal SAS

Manufacturer

Newdeal SAS