Events

Alerte Ou Avis De Sécurité sur K-Flow Access Catheters, Kimal High Flow (HF) Haemodialysis Catheters, Kimal Right Atrial (KRA) Catheters

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Kimal.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2010/072
  • Numéro de l'événement
    CON093950
  • Date
    2010-09-16
  • Date de publication de l'événement
    2010-09-16
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON093950?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The ce marking of these specific catheters is invalid.The safety and performance of these devices has not been submitted for independent assessment.
  • Action
    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...
  • Modèle / numéro de série
  • Description du dispositif
    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