Events

Safety blood collection and infusion sets 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Greiner Bio-One 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2013/047
  • 사례 연번
    CON287019
  • 날짜
    2013-06-27
  • 사례 출판 날짜
    2013-06-27
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON287019?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Risk of leakage of blood or infusion fluid, or under-filling of evacuated blood collection tubes or blood culture bottles. this product is being recalled due to potential cracking of the luer connector on these devices.
  • 조치
    Identify and quarantine affected products. Greiner Bio-One issued a Field Safety Notice (FSN) in March 2013 recalling affected products. Confirm receipt of the FSN to Greiner Bio-One and arrange for the return and replacement of unused affected devices.

Device

Safety blood collection and infusion sets
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Safety blood collection and infusion sets. Various item and lot numbers. The affected devices are illustrated below.  The area where the crack may occur is circled.  A list of the affected item codes and lot numbers are provided in the FSN .  The NHS Supply Chain codes (England only) corresponding to the manufacturer’s item codes are given as below. Safety infusion sets Greiner Bio-One code NHS supply chain code LOT numbers 450092 KFK 024 12H23 Safety blood collection sets with Luer adapter Greiner Bio-One code NHS supply chain code LOT numbers 450081 KFK 134 12H23, 12H24, 12I17, 12I26, 12H30 450082 KFK 136 12H21, 12H22, 12H30 450083 none 12I16 450084 none 12H29 450095 KFK 302 12H19, 12I22 450099 none 12H26 Safety blood collection sets with Luer adapter and holder Greiner Bio-One code NHS supply chain code LOT Numbers 450086 KFK 138 12H28, 12H25, 12H27, 12I26, 12I24, 12I25 Safety blood collection sets with blood culture holder Greiner Bio-One code NHS supply chain code LOT Numbers 450182 KFK 416 12H21, 12H30, 450184 KFK 418 12H22, 12H23, 450185 KFK 419 12H24, 12H23, 12I20
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One