Tag: infusion_pumps
-
FDA Early Alert Issued After Cardinal Health Updates Instructions for Presource Packs With BD Alaris Infusion Sets
BD testing found previously claimed infusion performance was overestimated, with deviations most common at rates under 1 mL/h and bolus volumes of 5 mL or less.
HealthBusinessLaw EnforcementMedical ScienceLegalFederal Government Product RecallFDACardinal HealthBD Alaris Pump Infusion SetsPresource PacksMedical DevicesEarly AlertFood RecallsDrugsBD Alaris Pump Infusion SetUS Food and Drug AdministrationMedical Device Recalls and Early Alerts ProgramInfusion pumps
-
FDA Alerts Public to Serious Infusion Pump Issues with Fresenius Kabi Ivenix Devices
The FDA has issued a serious alert for Fresenius Kabi's Ivenix Large Volume Infusion Pumps due to software and touchscreen issues. These corrections address risks of treatment delays or interruptions, with the FDA classifying them as the most serious type…
HealthBusinessScience & TechnologyMedical ScienceComputers and InternetFederal Government FDAFresenius KabiIvenixInfusion PumpsMedical DevicesProduct RecallSoftwareFood RecallsDrugs