BEUDAMED
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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 Tenacor with an impacted bezel repair part

    FDA Recall
    Terminated ·Tenacore LLC·Product code FRN·February 25, 2021

    Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410

    FDA Recall
    Terminated ·Tenacore LLC·Product code FRN·February 25, 2021

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Recall
    Terminated ·BioMedical Equipment Service Co (BMES)·Product code FRN·February 25, 2021

    Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

    FDA Recall
    Terminated ·STEP-HAR MEDICAL LLC·Product code FRN·February 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

    Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017

    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

    Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·June 21, 2007

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·June 21, 2007

    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; Product codes 2M8153 and 2M8163 (Colleague CX Triple)

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·June 21, 2007

    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; Product codes 2M8151 and 2M8161 (Colleague CX)

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·June 21, 2007

    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

    Harvard 1 Single Channel Syringe Infusion Pump, P/N 2003-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004