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 Kimal plc 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 026 05 15 001
  • 사례 시작날짜
    2015-06-03
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7732
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    The light glove may contain splits or holes or be torn.

Device

Devon Light Glove included in various Kimal Procedure Packs
  • 모델명 / 제조번호(시리얼번호)
    Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380/P1 Product Description: KFMC PAEDIATRIC PACK Product Code: SA-K41949/P1 Product Description: KKNGH CARDIOLOGY PACING PACK Product Code: SA-K42117 Product Description: KKNGH REVEAL PACK Product Code: SA-K42118 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K43714 Product Description: CAESARIAN-SECTION PACK PSCC Product Code: SPR/9911/45035 Product Description: KFNGH PAEDIATRIC CATH LAB PACK Product Code: SPR/9964/41494 Product Description: KFNGH ADULT CATH LAB PACK Product Code: SPR/9964/41495 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42508 Product Description: KKUH PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42865 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/43714 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/45033 Lot Numbers : Please see attached ..................... MHRA update code Multiple products and Lot numbers of the affected device are provided in the attached FSN.
  • 제품 설명
    This product is a disposable cover used in operating rooms
  • Manufacturer
    Kimal plc

Manufacturer

Kimal plc