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 Atrium Medical Corporation 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 039 10 18 000
  • 사례 시작날짜
    2018-10-11
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13290
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    This letter is intended to provide clarification about the current packaging configuration of the atrium ocean, oasis, express and express mini chest drainage products. atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is folded over and secured with the package label. this packaging system is the same configuration used on atrium chest drainage products for the past 30 years. this field notification is to provide clarification as to which part of the packaged drain is sterile. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile; the outer dust cover is not sterile. the two sterilization wraps are what provide the sterile barrier for the product.

Device

ATRIUM OCEAN, OASIS, EXPRESS and EXPRESS MINI CHEST DRAINS
  • 모델명 / 제조번호(시리얼번호)
    All Lot Numbers With Expiration Date Prior To October 2019
  • 제품 설명
    Water Seal Chest Drain
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • 제조사 모회사 (2017)
    Getinge AB
  • 제조사 대표
    Gulf Medical Co.
  • Source
    SFDA