Events

K-Flow Access Catheters, Kimal High Flow (HF) Haemodialysis Catheters, Kimal Right Atrial (KRA) Catheters 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Kimal 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/2010/072
  • 사례 연번
    CON093950
  • 날짜
    2010-09-16
  • 사례 출판 날짜
    2010-09-16
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON093950?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
    The ce marking of these specific catheters is invalid.The safety and performance of these devices has not been submitted for independent assessment.
  • 조치
    Identify the affected stock and return it to the manufacturer. For patients with catheters in situ, the MHRA currently considers that the benefits of continuing to use the device outweigh the risks of removal and replacement.

Device

K-Flow Access Catheters, Kimal High Flow (HF) Haemodialysis Catheters, Kimal Right Atrial (KRA) C...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Vascular catheters: K-Flow Access Catheters. Kimal High Flow (HF) Haemodialysis Catheters. Kimal Right Atrial (KRA) Catheters. Devices with specific product codes and expiry dates are affected. To identify affected devices you will need to check the expiry date as well as the product code. The expiry dates are visible on the packaging and will be in the format YYYY-MM e.g. 2014-04 for April 2014. The affected catheters are: K-Flow Access Catheters with expiry dates from 2013-10 to 2015 -06 inclusive. Kimal High Flow (KHF) Haemodialysis Catheters with expiry dates from 2011-09 to 2015 -06 inclusive. Kimal Right Atrial (KRA) Catheters with expiry dates from 2012-09 to 2014 -01inclusive. Product Name Product Codes French size (Fr) Expiry Dates (inclusive) NHS Supply Codes Short Term K-Flow Access 360 Temporary KF360T/1512/1J KF360T/1515/1J KF360T/1520/1J KF360T/1515/S KF360T/1520/S KF360T/1524/S KF360T/1528/S 15.5 15.5 15.5 15.5 15.5 15.5 15.5 2013-10 to 2015 -06 - - - - - - - Short Term K-Flow Access Temporary KFT1213C KFT1213S KFT1215C KFT1215S KFT1220C KFT1220S KFT1224C KFT1224S KFTT1215C KFTT1215S KFTT1220C KFTT1220S KFTT1224S 12 12 12 12 12 12 12 12 12 12 12 12 12 2013-10 to 2015 -06 - - - - - - - - FSQ915 FSQ909 FSQ916 FSQ911 FSQ913 Short Term K-Flow Access PICC-CT KFPCT5S KFPCT6D 5 6 2013-10 to 2015 -06 - - Short Term K-Flow Access PICC KFMP5 KFP3S KFP4D KFP4S KFP5D KFP5S KFP6D 5 3 4 4 5 5 6 2013-10 to 2015 -06 - - FSU337 FSU335 FSU338 FSU336 FSU339 Long Term K-Flow Access Haemo KFH1424C KFH1424S KFH1428C KFH1428S KFH1432C KFH1432S KFH1436S 14.5 14.5 14.5 14.5 14.5 14.5 14.5 2013-10 to 2015 -06 - - - - - - - Long Term K-Flow Access Split KFS1524 KFS1528 KFS1532 KFS1540 15.5 15.5 15.5 15.5 2013-10 to 2015 -06 - - - - Long Term K-Flow Access Stepped Silicone KFSL1428 KFSL1432 14 14 2013-10 to 2015 -06 - - Long Term K-Flow Access Right Atrial KFRA125T KFRA95D KFRA7S KFRA95S 12.5 9.5 7 9.5 2013-10 to 2015 -06 - - - - Long Term Kimal High Flow (aka KHF) KHF24 KHF24/k KHF24/K/LGH KHF28 KHF28/K KHF28/K/LGH KHF32 KHF32/K KHF36 KHF36/K 14.5 14.5 14.5 14.5 14.5 14.5 14.5 14.5 14.5 14.5 2011-09 to 2015 -06 - - - - - - - - - - Long Term Kimal Right Atrial (aka KRA) KRA95D/KGY KRA95S/K 9.5 9.5 2012-09 to 2014 -01 - - -
  • Manufacturer
    Kimal

Manufacturer

Kimal