BEUDAMED
    2 results · 5ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Ongoing × Clear all

    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

    FDA Enforcement
    Class I ·Ongoing·Fresenius Kabi USA, LLC·June 10, 2026

    BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide

    FDA Enforcement
    Class I ·Ongoing·CareFusion 303, Inc.·November 26, 2025