BEUDAMED
    28 results · 45ms · Sources: EU EUDAMED, US FDA

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    Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part

    FDA Recall
    Open, Classified ·Infusion Pump Repair·Product code FRN·March 26, 2021

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

    FDA Recall
    Open, Classified ·The Biomed Guys·Product code FRN·March 25, 2021

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 19, 2024

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 19, 2024

    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 Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·October 17, 2025

    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·March 3, 2021

    Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

    FDA Recall
    Open, Classified ·Pacific Medical Group Inc.·Product code FRN·March 24, 2021

    Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 3, 2015

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

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·December 6, 2024

    Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code MRZ·December 19, 2023

    Baxter Novum IQ Syringe Pump, product code 40800BAXUS,

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·May 12, 2025

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023

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

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·November 29, 2023

    Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·March 10, 2023

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

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·September 3, 2025

    Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 15, 2024

    Alaris System PC Unit Model 8015

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·August 4, 2020