Pump, Infusion
FDA product code FRN · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital
849510(k) clearances
0PMA approvals
670recalls
Manufacturers
- Abbott Laboratories 67
- Baxter Healthcare Corp 51
- Y 26
- Travenol Laboratories, S.A. 23
- C.R. Bard, Inc. 22
- Imed Corp. 22
- 3M Health Care, Ltd. 16
- 3M Avi, Inc. 16
- Bd Becton Dickinson Vacutainer Systems Preanalytic 14
- I-Flow Corp. 13
- Medtronic Minimed 13
- Avi, Inc. 13
- Hospira Inc. 12
- B. Braun Medical, Inc. 11
- Pharmacia Deltec, Inc. 10
- Windsor Medical, Inc. 8
- Caesarea Medical Electronics , Ltd. 8
- Cardiac Pacemakers, Inc. 8
- Disetronic Medical Systems 8
- 3M Company 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser…FRN · Traditional | Belmont Medical Technologies | 12/23/2024SE |
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Special | Zevex, Inc. | 10/03/2024SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | Baxter Healthcare Corporation | 09/05/2024SE |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…FRN · Traditional | Zevex, Inc. | 05/17/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | Baxter Healthcare Corporation | 03/29/2024SE |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing…FRN · Traditional | Koru Medical Systems | 11/03/2023SE |
| K230083 | SafiraFRN · Traditional | Medovate Limited | 10/31/2023SE |
| K223607 | Plum Duo Infusion SystemFRN · Traditional | Icu Medical, Inc. | 08/24/2023SE |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2FRN · Traditional | Carefusion 303, Inc. | 07/21/2023SE |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRN · Traditional | Baxter Healthcare Corporation | 03/31/2023SE |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 03/31/2023SE |
| K213744 | Avoset Infusion Pump SystemFRN · Traditional | Eitan Medical , Ltd. | 03/10/2023SE |
| K222048 | Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRN · Traditional | Baxter Healthcare Corporation | 09/06/2022SE |
| K211125 | Novum IQ Syringe PumpFRN · Traditional | Baxter Healthcare Corporation | 08/30/2022SE |
| K220417 | Spectrum IQ Infusion System with Dose IQ Safety SoftwareFRN · Traditional | Baxter Healthcare Corporation | 04/29/2022SE |
| K214045 | FreedomEdge Syringe Infusion SystemFRN · Traditional | Repro-Medical System, Inc., Dba Koru Medical… | 04/29/2022SE |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…FRN · Traditional | Fresenius Kabi AG | 03/01/2022SE |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…FRN · Traditional | Fresenius Kabi AG | 03/01/2022SE |
| K200176 | FREEDOM Integrated Syringe Infusion SystemFRN · Traditional | Repro-Med Systems, Inc. Dba Koru Medical Systems | 12/15/2021SE |
| K211206 | FreedomEdge(R) Syringe Infusion SystemFRN · Traditional | Repro-Medical System, Inc., Dba Koru Medical… | 11/09/2021SE |
| K192860 | Sapphire Infusion Pump, Sapphire administration setsFRN · Traditional | Q Core Medical , Ltd. | 11/19/2020SE |
| K183311 | Ivenix Infusion System (IIS)FRN · Traditional | Ivenix, Inc. | 06/07/2019SE |
| K190182 | Unity Subcutaneous Delivery System for RemodulinFRN · Traditional | DEKA Research & Development | 05/06/2019SE |
| K172653 | Power InfuserFRN · Traditional | ZOLL Medical Corporation | 07/18/2018SE |
| K172831 | Perfusor® Space Syringe Infusion Pump SystemFRN · Traditional | B.Braun Medical, Inc. | 06/12/2018SE |
| K173084 | Spectrum IQ Infusion System, Dose IQ Safety SoftwareFRN · Traditional | Baxter Healthcare Corporation | 05/11/2018SE |
| K162613 | Integrated Catch-up Freedom Syringe Driver Infusion SystemFRN · Traditional | Repro-Med Systems, Inc. Dba Rms Medical Products | 08/31/2017SE |
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | Hospira, Inc. | 03/28/2017SE |
| K161667 | Sapphire Infusion PumpFRN · Traditional | Q Core Medical , Ltd. | 03/27/2017SE |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring SystemFRN · Traditional | Iradimed Corporation | 12/15/2016SE |
| K153599 | Concert Medical Hands-Free Syringe (HFS)FRN · Traditional | Concert Medical, LLC | 09/01/2016SE |
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…FRN · Abbreviated | Zyno Medical, LLC | 08/30/2016SE |
| K151255 | Navigator Aesthetic Delivery SystemFRN · Traditional | Carticept Medical, Inc. | 12/30/2015SE |
| K142596 | Infusomat Space Volumetric Infusion PumpFRN · Traditional | B.Braun Medical, Inc. | 06/18/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | Hospira, Inc. | 01/16/2015SE |
| K141389 | Sapphire Infusion PumpFRN · Traditional | Q Core Medical , Ltd. | 12/11/2014SE |
| K140783 | Halo Ambulatory Infusion SystemFRN · Abbreviated | Zyno Medical, LLC | 10/17/2014SE |
| K133532 | Alaris System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 08/21/2014SE |
| K141654 | The Belmont Rapid InfuserFRN · Special | Belmont Instrument Corporation | 07/18/2014SE |
| K141102 | Hospira Mednet Medication Management SuiteFRN · Special | Hospira, Inc. | 07/08/2014SE |
| K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 05/07/2014SE |
| K123049 | Sapphire Infusion PumpFRN · Traditional | Q Core Medical , Ltd. | 10/17/2013SE |
| K123822 | Klein Touch Pump and Disposable Tubing SetFRN · Traditional | Hk Surgical, Inc. | 09/27/2013SE |
| K130690 | Z-800 Infusion SystemFRN · Special | Zyno Medical, LLC | 06/12/2013SE |
| K121613 | Agilia Infusion SystemFRN · Traditional | Fresenius Kabi AG | 05/01/2013SE |
| K124053 | Navigator Delivery System (Navigator DS)FRN · Special | Carticept Medical, Inc. | 03/13/2013SE |
| K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareFRN · Traditional | Smiths Medical Asd, Inc. | 02/01/2013SE |
| K122215 | Navigator Delivery System (Navigator DS)FRN · Special | Carticept Medical, Inc. | 10/26/2012SE |
| K120830 | Navigator Delivery System (Navigator DS)FRN · Special | Carticept Medical, Inc. | 04/16/2012SE |
| K110535 | Alaris PC Unit Module 8000 with Software CorrectionFRN · Traditional | Carefusion 303, Inc. | 03/26/2012SE |
| K110901 | Symbiq Infusion and Adminstration SetFRN · Traditional | Hospira, Inc. | 03/05/2012SE |
| K112067 | Navigator Delivery System (Navigator DS)FRN · Traditional | Carticept Medical, Inc. | 09/16/2011SE |
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…FRN · Traditional | Smiths Medical MD, Inc. | 08/29/2011SE |
| K101194 | Navigator Delivery System (or Navigator DS) Model: NAV-010FRN · Traditional | Carticept Medical, Inc. | 07/11/2011SE |
| K100705 | Zyno Z-800 Infusion System Model Z-800FRN · Abbreviated | Zyno Medical, LLC | 07/08/2010SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | Medrad, Inc. | 06/23/2010SE |
| K100704 | Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion DeviceFRN · Special | Disetronic Medical Systems AG | 05/14/2010SE |
| K093332 | Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02XXXX (Where X…FRN · Traditional | Delphi Medical Systems | 12/09/2009SE |
| K091441 | Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetFRN · Traditional | Synergetics, Inc. | 10/30/2009SE |
| K091386 | Microfuse Dual Rate InfuserFRN · Special | Numia Medical Technology, LLC | 10/02/2009SE |
| K091308 | Alaris PC Unit, Models 8000 and 8015FRN · Traditional | Cardinal Health 303,Inc. | 07/09/2009SE |
| K091855 | The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000FRN · Special | Belmont Instrument Corp. | 07/01/2009SE |
| K083689 | Infusomat Space Volumetric Infusion Pump SystemFRN · Traditional | B.Braun Medical, Inc. | 07/01/2009SE |
| K090736 | Power Infuser, Model M100B-3AFRN · Traditional | ZOLL Medical Corporation | 05/20/2009SE |
| K091042 | Crono S-Pid 50FRN · Special | Cane S.R.L. | 05/12/2009SE |
| K090087 | Mridium 3860 MRI Infusion Pump/Monitoring SystemFRN · Traditional | Iradimed Corporation | 04/07/2009SE |
| K081412 | Plum A+ Hyperbaric Infusion System with Hospira Mednet SoftwareFRN · Traditional | Hospira, Inc. | 12/17/2008SE |
| K072603 | Abc Syringe Infusion Pump, Model 4100FRN · Traditional | Elixir Corporation | 10/23/2008SE |
| K083019 | Gemstar SP Infusion System with Gemstar SP Infusion Suite SoftwareFRN · Traditional | Hospira, Inc. | 10/22/2008SE |
| K082182 | Ap 34 Multi-Therapy Infusion PumpFRN · Traditional | Q-Core, Ltd. | 08/15/2008SE |
| K080297 | Medrad Intego PET Infusion SystemFRN · Traditional | Medrad, Inc. | 06/17/2008SE |
| K073051 | Medrad Continuum MR Infusion System with Wireless Remote AccessoryFRN · Abbreviated | Medrad, Inc. | 05/30/2008SE |
| K080954 | T34L Syringe DriverFRN · Special | Caesarea Medical Electronics , Ltd. | 05/16/2008SE |
| K080743 | Lockbox for Use with Cadd Solis Infusion PumpFRN · Traditional | Smiths Medical MD, Inc. | 04/25/2008SE |
| K072105 | Alaris System with MMS, Model 8XXXFRN · Special | Cardinal Health 303,Inc. | 12/28/2007SE |
| K071588 | Dispenser DP 20FRN · Traditional | Nouvag AG | 11/26/2007SE |
| K071545 | Z-800 Volumetric Infusion PumpFRN · Traditional | Zyno Medical, LLC | 10/31/2007SE |
| K070235 | Bodyguard Pain Manager Infusion SystemFRN · Special | Caesarea Medical Electronics , Ltd. | 05/18/2007SE |
| K070529 | Aff (Mark I) Volumetric Infusion PumpFRN · Traditional | Definitive Medical Technologies, Ltd. | 05/08/2007SE |
| K070398 | Hospira Plum A+ Infusion Pump, Model 12391FRN · Special | Hospira, Inc. | 04/24/2007SE |
| K070125 | Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software…FRN · Traditional | Baxter Healthcare Corp | 04/16/2007SE |
| K070718 | Modification to: Bodyguard Infusion SystemFRN · Special | Caesarea Medical Electronics , Ltd. | 04/13/2007SE |
| K063696 | Colleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163FRN · Traditional | Baxterhealthcare, Inc. | 02/27/2007SE |
| K070268 | Signature Edition Infusion System, Models 710X, 720XFRN · Special | Cardinal Health 303,Inc. | 02/23/2007SE |
| K061108 | Stryker Auto Irrigation SystemFRN · Traditional | Stryker | 02/02/2007SE |
| K052973 | Ipump Pain Management System, Model 2L3107, 2L3107KFRN · Traditional | Baxter Healthcare Corp | 01/25/2007SE |
| K062592 | Cadd-Sentry Pro Medication Safety SoftwareFRN · Traditional | Smiths Medical MD, Inc. | 11/29/2006SE |
| K063288 | Signature Edition Gold Infusion System, Model 7X3XFRN · Special | Cardinal Health 303,Inc. | 11/28/2006SE |
| K062700 | Infusomat Space Volumetric Infusion Pump SystemFRN · Traditional | B.Braun Medical, Inc. | 10/26/2006SE |
| K062699 | Perfusor Space Infusion Syringe Pump SystemFRN · Traditional | B.Braun Medical, Inc. | 10/26/2006SE |
| K061325 | Bodygaurd Pain Manager Infusion SystemFRN · Abbreviated | Caesarea Medical Electronics , Ltd. | 08/24/2006SE |
| K053554 | CompufloFRN · Traditional | Milestone Scientific, Inc. | 07/10/2006SE |
| K061128 | Modification to Medrad Continuum MR Infusion SystemFRN · Special | Medrad, Inc. | 05/22/2006SE |
| K060479 | Modification to Bodyguard Infusion Pump SystemFRN · Traditional | Caesarea Medical Electronics , Ltd. | 05/12/2006SE |
| K060806 | Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086…FRN · Special | Hospira, Inc. | 04/21/2006SE |
| K052817 | Eureka Infusion Pump, Models Eureka-Ip, Eureka-LfFRN · Traditional | Universal Medical Technologies | 04/17/2006SE |
| K060119 | Mckinley Saturation CatheterFRN · Traditional | Mckinley Medical, LLC | 04/12/2006SE |
| K052594 | Willcare, Model GW-1020FRN · Traditional | Icu Medical, Inc. | 02/10/2006SE |
| K053226 | Zimmer Ambulatory Pump Pain Management Systems with Fenestrated Catheter and Flow SplitterFRN · Traditional | Zimmer, Inc. | 01/31/2006SE |
| K052221 | Ambit Push & Play Ambulatory Infusion PumpFRN · Abbreviated | Sorenson Medical, Inc. | 12/08/2005SE |
| K052218 | Crono Five and Crono Pca 50FRN · Traditional | Cane S.R.L. | 11/23/2005SE |
| K050800 | Niki T34 and Bodyguard T34 Syringe DriversFRN · Traditional | Caesarea Medical Electronics , Ltd. | 11/23/2005SE |
| K051568 | Cadd-Ms 3 Ambulatory Infusion PumpFRN · Traditional | Smiths Medical MD, Inc. | 11/17/2005SE |
| K051641 | Alaris System PC Unit, Model 8001FRN · Traditional | Cardinal Health, Alaris Products | 10/20/2005SE |
| K052171 | Zimmer Ambulatory Pump Pain Management System with Patient Control ModuleFRN · Traditional | Zimmer, Inc. | 10/13/2005SE |
| K052219 | Crono Go.FRN · Special | Cane S.R.L. | 09/13/2005SE |
| K052217 | Crono Super PidFRN · Special | Cane S.R.L. | 09/13/2005SE |
| K052052 | Hospira Plum A+ Infusion Pump System V11.5, Hospira Plum A+ 3 Infusion Pump System, V11.5FRN · Special | Hospira, Inc. | 08/24/2005SE |
| K051045 | Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30FRN · Special | Spectrx, Inc. | 08/02/2005SE |
| K051252 | Micropump MP-101FRN · Traditional | Micrel Medical Devices S.A. | 05/27/2005SE |
| K043466 | PAINPUMP2FRN · Traditional | Stryker Instruments | 05/10/2005SE |
| K050324 | Infpump Infiltration PumpFRN · Traditional | Carolina Medical, Inc. | 04/27/2005SE |
| K050474 | Veinnovations Infiltration SystemFRN · Traditional | Veinnovations, LLC | 04/14/2005SE |
| K050433 | Zimmer Ambulatory Pump Pain Management SystemFRN · Traditional | Zimmer Orthopaedic Surgical Products | 04/13/2005SE |
| K043204 | Sgarlato Labs Painfree Pump and Pain Control Infusion PumpFRN · Traditional | Sgarlato Laboratories, Inc. | 03/30/2005SE |
| K043600 | Medtronic Micromed 407C Infusion Pump, Model MMT-407CFRN · Traditional | Medtronic Minimed | 03/29/2005SE |
| K043590 | Se Infusion System with MMSFRN · Traditional | Cardinal Health, Alaris Products | 03/25/2005SE |
| K050301 | Mridium 3850 MRI Pump SystemFRN · Traditional | Iradimed Corporation | 03/24/2005SE |
| K042696 | Bodyguard Infusion Pump SystemFRN · Traditional | Caesarea Medical Electronics , Ltd. | 03/11/2005SE |
| K050107 | Harvard 2 Syringe Pump, Model 2001-001FRN · Special | Harvard Clinical Technology | 02/11/2005SE |
| K042432 | Pharmguard Toolbox, Model G6000782FRN · Traditional | Medex, Inc. | 01/04/2005SE |
| K040985 | Pump Connectivity InterfaceFRN · Traditional | Baxter Healthcare Corp | 11/30/2004SE |
| K042980 | Hospira Gemstar Infusion Pump System, Hospira Gemstar Connect SoftwareFRN · Special | Hospira, Inc. | 11/17/2004SE |
| K042228 | Beeline Motiv, Propolis, PcaFRN · Traditional | Mckinley, Inc. | 11/08/2004SE |
| K042405 | PAINPUMP1; PAINPUMP2FRN · Traditional | Stryker Corp. | 10/14/2004SE |
| K042609 | Hospira Mednet Medication Management SuiteFRN · Traditional | Hospira, Inc. | 10/06/2004SE |
| K041714 | E-Pain CareFRN · Traditional | Breg, Inc. | 10/01/2004SE |
| K042085 | Crono FFRN · Special | Cane S.R.L. | 09/17/2004SE |
| K042121 | Spectrum and Spectrum with Master Drug LibraryFRN · Traditional | Sigma Intl. | 08/26/2004SE |
| K042081 | Plum A+ Infusion System with Hospira Mednet Software , and Plum A+3 Infusion System with…FRN · Traditional | Hospira, Inc. | 08/24/2004SE |
| K041738 | Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)FRN · Special | Baxter Healthcare Corporation | 07/09/2004SE |
| K041414 | Crono and Crono, Model 30FRN · Special | Cane S.R.L. | 07/08/2004SE |
| K041241 | Medley System with Bar Code Module, Model 8600FRN · Traditional | Alaris Medical Systems, Inc. | 07/06/2004SE |
| K041550 | Hospira Phoenix Infusion System with Hospira Mednet SoftwareFRN · Traditional | Abbott Laboratories | 06/30/2004SE |
| K041191 | Colleague Volumetric Infusion PumpsFRN · Traditional | Baxter Healthcare Corp | 06/25/2004SE |
| K040149 | Psi-Tec Peristaltic Infiltration PumpFRN · Traditional | Byron Medical | 06/03/2004SE |
| K041152 | Thinset 1.8 ML Reservoir, Model 326A; Thinset 3.0 ML Reservoir, Model 332AFRN · Special | Applied Diabetes Research, Inc. | 05/24/2004SE |
| K040899 | Medex 3000 Series MR Syringe Infusion PumpFRN · Traditional | Medex, Inc. | 04/30/2004SE |
| K040061 | Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407CFRN · Traditional | Medtronic Minimed | 04/08/2004SE |
| K040114 | Abbott Data Port PC, Model 12181FRN · Special | Abbott Laboratories | 01/29/2004SE |
| K030739 | Infusion Dynamics (Id) Power Infuser, Model M100B-3A with Blood CartridgeFRN · Traditional | Infusion Dynamics, Inc. | 01/14/2004SE |
| K033425 | Ambit Intermittent Ambulatory Infusion PumpFRN · Special | Sorenson Medical, Inc. | 11/06/2003SE |
| K033325 | Ambit Continuous Ambulatory Infusion PumpFRN · Special | Sorenson Medical, Inc. | 11/06/2003SE |
| K032789 | Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door…FRN · Traditional | American I.V. Products, Inc. | 10/09/2003SE |
| K032771 | Medrad Continuum MR Infusion SystemFRN · Special | Medrad, Inc. | 09/23/2003SE |
| K032642 | Beeline SystemFRN · Special | Mckinley, Inc. | 09/23/2003SE |
| K032005 | Medtronic Minimed Paradigm Reservoir, Model MMT-332FRN · Traditional | Medtronic Minimed | 08/22/2003SE |
| K031749 | Bodyguard Infusion SystemFRN · Traditional | Caesarea Medical Electronics , Ltd. | 08/21/2003SE |
| K031600 | Conduction CatheterFRN · Traditional | Micor, Inc. | 08/13/2003SE |
| K031432 | Klein Surgical Infiltration Pump, Model Kip-IiFRN · Abbreviated | Hk Surgical, Inc. | 08/07/2003SE |
| K032147 | Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…FRN · Special | Alaris Medical Systems, Inc. | 07/25/2003SE |
| K031249 | Modification to Stryker PainpumpFRN · Traditional | Stryker Instruments | 07/21/2003SE |
| K030576 | Anspach Irrigation Pump and Irrigation Pump IIFRN · Traditional | The Anspach Effort, Inc. | 05/21/2003SE |
| K031185 | Abbott Plum A+ Infusion Pump with a Hpl/Rs Plug-And-Play ModuleFRN · Traditional | Abbott Laboratories | 04/30/2003SE |
| K030885 | Modification to Stryker PAINPUMP2FRN · Special | Stryker Instruments | 04/18/2003SE |
| K030459 | Medley System with Medication Management System (MMS)FRN · Traditional | Alaris Medical Systems, Inc. | 04/04/2003SE |
| K030323 | Mri-CaddyFRN · Traditional | Mammendorfer Institute For Physics & Medicine GmbH | 04/02/2003SE |
| K023189 | Vista Basic with FM SystemFRN · Traditional | B.Braun Medical, Inc. | 03/20/2003SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | Promedic, Inc. | 03/17/2003SE |
| K023083 | Silberg T.P.S., Tissue Preparation System, Model Me 800FRN · Abbreviated | Mettler Electronics Corp. | 02/28/2003ST |
| K023973 | Automed 3200 Infusion PumpFRN · Traditional | Help Technologies | 02/27/2003SE |
| K023863 | Automed 3000 Infusion PumpFRN · Traditional | Help Technologies | 02/07/2003SE |
| K024056 | Sureset 3.0 ML Reservoir, Model 24-103FRN · Traditional | Applied Diabetes Research, Incorporated | 01/17/2003SE |
| K024084 | Abbott Plum A+ Infusion Pump, Model 12391FRN · Special | Abbott Laboratories | 12/31/2002SE |
| K023264 | Medley Syringe Pump Module System, Model 8110FRN · Traditional | Alaris Medical Systems, Inc. | 12/19/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | I-Flow Corp. | 12/13/2002SE |
| K023491 | Automed 3300 and 3400 Infusion Pump SystemFRN · Traditional | Help Technologies | 12/13/2002SE |
| K023062 | Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain ManagementFRN · Special | Abbott Laboratories, Inc. | 09/30/2002SE |
| K022869 | Soaker CatheterFRN · Special | I-Flow Corp. | 09/20/2002SE |
| K021988 | Medrad Continuum MR Compatible Infusion SystemFRN · Abbreviated | Medrad, Inc. | 08/29/2002SE |
| K022575 | Perfusor Compact with FM SystemFRN · Traditional | B.Braun Medical, Inc. | 08/21/2002SE |
| K021350 | Abbott Plum A+3 Multichannel Infusion Pump, Model 12348FRN · Special | Abbott Laboratories | 05/14/2002SE |
| K013840 | Microjet Crono Par and Crono Apo-GoFRN · Traditional | Cane S.R.L. | 05/14/2002SE |
| K013855 | Microjet Crono HFRN · Traditional | Cane S.R.I. | 05/09/2002SE |
| K013776 | Microjet Model # CD4 and CD4/20FRN · Traditional | Cane S.R.I. | 04/26/2002SE |
| K013234 | Microjet CronoFRN · Traditional | Cane S.R.L. | 04/26/2002SE |
| K020947 | Modification to Dyonics Intelijet Reusable CannulasFRN · Special | Smith & Nephew, Inc. | 04/17/2002SE |
| K020881 | Modification to Personal Infusor Local Pain Management Procedural KitFRN · Special | Science Incorporated | 03/27/2002SE |
| K020251 | Paragon Infusion SystemFRN · Special | I-Flow Corp. | 02/15/2002SE |
| K014091 | Stryker PainpumpFRN · Special | Stryker Corp. | 12/31/2001SE |
| K013767 | Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an…FRN · Traditional | Sterling Medivations, Inc. | 12/12/2001SE |
| K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (Se), Medsystem III…FRN · Traditional | Alaris Medical Systems, Inc. | 10/02/2001SE |
| K011975 | Horizon Outlook with DosecomFRN · Traditional | B.Braun Medical, Inc. | 09/19/2001SE |
| K012044 | Bi-Phasic InfiltratorFRN · Traditional | Reliance Medical Corp. | 08/28/2001SE |
| K003966 | Wundcath Conduction CatheterFRN · Traditional | Micor, Inc. | 07/17/2001SE |
| K010937 | SEP-10S Plus, and SP-12S Pro.FRN · Traditional | Viltechmeda | 06/25/2001SE |
| K011442 | Abbott Plum A+Infusion Pump, Model 11971FRN · Special | Abbott Laboratories | 06/05/2001SE |
| K003543 | Stryker Painpump PcaFRN · Traditional | Stryker Instruments | 06/05/2001SE |
| K010566 | Colleague Volumetric Infusion PumpFRN · Traditional | Baxter Healthcare Corp | 05/15/2001SE |
| K011096 | Abbott Acclaim Encore, Model 12237FRN · Special | Abbott Laboratories | 05/01/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3066-2026 Class II | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches… | Baxter Healthcare Corporation | 08/11/2026Open, Classified |
| Z-3065-2026 Class II | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches… | Baxter Healthcare Corporation | 08/11/2026Open, Classified |
| Z-2724-2026 Class II | ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the… | ICU Medical, Inc. | 06/10/2026Open, Classified |
| Z-2723-2026 Class II | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the… | ICU Medical, Inc. | 06/10/2026Open, Classified |
| Z-3162-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | ICU Medical, Inc. | 05/12/2026Open, Classified |
| Z-2224-2026 Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP… | Fresenius Kabi USA, LLC | 05/06/2026Open, Classified |
| Z-2223-2026 Class I | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%)… | Fresenius Kabi USA, LLC | 05/06/2026Open, Classified |
| Z-2313-2026 Class II | Plum Duo Precision IV Pump, 40002-0403Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of… | ICU Medical, Inc. | 04/29/2026Open, Classified |
| Z-2312-2026 Class II | Plum Duo Infusion Pump, 40002-0401Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of… | ICU Medical, Inc. | 04/29/2026Open, Classified |
| Z-2311-2026 Class II | Plum Solo Precision IV Pump, 40001-0401Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of… | ICU Medical, Inc. | 04/29/2026Open, Classified |
| Z-1645-2026 Class II | BD Alaris" System with Guardrails" Suite MX with Point of Care UnitDue to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on… | CareFusion 303, Inc. | 02/11/2026Open, Classified |
| Z-2274-2026 Class II | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Potential for the Cassette Loading Lever to break. | Fresenius Kabi USA, LLC | 02/04/2026Open, Classified |
| Z-1368-2026 Class II | Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009…Pumps were released without full testing being performed, including occlusion alarm testing. | Baxter Healthcare Corporation | 01/13/2026Open, Classified |
| Z-1120-2026 Class II | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001…Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream… | ICU Medical, Inc. | 12/15/2025Open, Classified |
| Z-1119-2026 Class II | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003…Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream… | ICU Medical, Inc. | 12/15/2025Open, Classified |
| Z-1118-2026 Class II | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream… | ICU Medical, Inc. | 12/15/2025Open, Classified |
| Z-1094-2026 Class II | Plum Duo Infusion System, List Number 40002-04-01ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an… | ICU Medical, Inc. | 12/15/2025Open, Classified |
| Z-1121-2026 Class II | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2Certain pumps have potentially been released from service with defective grease applied to the cam and motor… | Baxter Healthcare Corporation | 11/28/2025Open, Classified |
| Z-1048-2026 Class II | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Emphasizing instructions for LVP duration programming located in the IFU. | Fresenius Kabi USA, LLC | 11/21/2025Open, Classified |
| Z-0885-2026 Class I | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled…Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm… | Fresenius Kabi USA, LLC | 11/14/2025Open, Classified |
| Z-1217-2026 Class II | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System…Due to a number of modules flashed with a date and time associated with the daylight savings time (DST)… | CareFusion 303, Inc. | 11/06/2025Open, Classified |
| Z-0848-2026 Class II | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is… | Fresenius Kabi USA, LLC | 11/03/2025Open, Classified |
| Z-0586-2026 Class I | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing…Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient… | Fresenius Kabi USA, LLC | 11/03/2025Open, Classified |
| Z-0430-2026 Class I | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437…If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can… | CareFusion 303, Inc. | 10/17/2025Open, Classified |
| Z-0378-2026 Class II | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the… | Fresenius Kabi USA, LLC | 09/03/2025Open, Classified |
| Z-2334-2025 Class I | Novum IQ Syringe Pump, Product Code 40700BAX, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2333-2025 Class I | Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2332-2025 Class I | Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2415-2025 Class II | Spectrum IQ Infusion Pump, Product Code 3570009Baxter has identified that certain pumps have potentially been released with the grease applied to the cam… | Baxter Healthcare Corporation | 07/14/2025Open, Classified |
| Z-2173-2025 Class I | Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSBaxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the… | Baxter Healthcare Corporation | 07/14/2025Open, Classified |
| Z-2129-2025 Class I | Plum Duo Infusion System, List Number: 400020401ICU Medical identified two sequences of programming events and alarm interactions that may cause the user… | ICU Medical, Inc. | 07/11/2025Open, Classified |
| Z-2180-2025 Class I | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check…Infusion pump module used with compatible pump infusion sets may perform outside the established performance… | CareFusion 303, Inc. | 07/08/2025Open, Classified |
| Z-2179-2025 Class I | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsInfusion pump module used with compatible pump infusion sets may perform outside the established performance… | CareFusion 303, Inc. | 07/08/2025Open, Classified |
| Z-2235-2025 Class II | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site…Potential for external cassette leaks | Fresenius Kabi USA, LLC | 06/24/2025Open, Classified |
| Z-2234-2025 Class II | LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code:…Potential for external cassette leaks | Fresenius Kabi USA, LLC | 06/24/2025Open, Classified |
| Z-2233-2025 Class II | LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty…Potential for external cassette leaks | Fresenius Kabi USA, LLC | 06/24/2025Open, Classified |
| Z-2232-2025 Class II | LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty…Potential for external cassette leaks | Fresenius Kabi USA, LLC | 06/24/2025Open, Classified |
| Z-1964-2025 Class II | Baxter Novum IQ Syringe Pump, product code 40800BAXUS,Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange… | Baxter Healthcare Corporation | 05/12/2025Open, Classified |
| Z-1868-2025 Class I | Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1867-2025 Class I | Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1866-2025 Class I | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1865-2025 Class I | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1767-2025 Class I | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSThere is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the… | Baxter Healthcare Corporation | 04/24/2025Open, Classified |
| Z-1991-2025 Class II | ICU Medical Plum Solos, Item number 400011001; infusion pumpInternal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in… | ICU Medical, Inc. | 04/22/2025Open, Classified |
| Z-1990-2025 Class II | ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003…Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in… | ICU Medical, Inc. | 04/22/2025Open, Classified |
| Z-1682-2025 Class I | CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120…There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. | Smiths Medical ASD, Inc. | 04/10/2025Open, Classified |
| Z-1668-2025 Class I | CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03…Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which… | Smiths Medical ASD, Inc. | 04/10/2025Open, Classified |
| Z-1423-2025 Class II | Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUSBaxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps… | Baxter Healthcare Corporation | 03/03/2025Open, Classified |
| Z-1254-2025 Class I | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009There is the potential for missing motor mounting screws, which may have occurred during the servicing… | Baxter Healthcare Corporation | 02/05/2025Open, Classified |
| Z-1253-2025 Class I | Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAXThere is the potential for missing motor mounting screws, which may have occurred during the servicing… | Baxter Healthcare Corporation | 02/05/2025Open, Classified |