Warmer, Thermal, Infusion Fluid
FDA product code LGZ · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital
75510(k) clearances
0PMA approvals
33recalls
Manufacturers
- Belmont Instrument Corp. 6
- Quality IN Flow , Ltd. 5
- STERIS Corporation 3
- C.F. Electronics, Inc. 3
- Medical Solutions, Inc. 3
- Vital Signs, Inc., A GE Healthcare Company 2
- Life Warmer, Inc. 2
- Elltec Co., Ltd. 2
- Automatic Medical Technologies, Inc. 2
- Enthermics Medical Systems, Inc. 2
- Datachem, Inc. 2
- The Surgical Company International B.V. 2
- Mequ A/S 2
- Rand S.R.L. 2
- Medadvances, Inc. 2
- Smisson-Cartledge Biomedical, LLC 2
- Arizant Healthcare, Inc. 2
- Smith 1
- The Surgical Company International BV (As Tsc Life) 1
- Pmt Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260988 | °M Warmer System with °M StationLGZ · Special | Mequ A/S | 04/24/2026SE |
| K252636 | Fluido Compact SystemLGZ · Traditional | The Surgical Company International B.V. | 11/18/2025SE |
| K251733 | Fluido® AirGuard SystemLGZ · Traditional | The Surgical Company International BV (As Tsc… | 09/04/2025SE |
| K232107 | °M Warmer SystemLGZ · Traditional | Mequ A/S | 05/31/2024SE |
| K211618 | Fluido Compact Blood and Fluid Warming SystemLGZ · Traditional | The Surgical Company International B.V. | 06/05/2023SE |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite…LGZ · Traditional | Quality IN Flow , Ltd. | 12/08/2022SE |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemLGZ · Traditional | Smisson-Cartledge Biomedical, LLC | 08/12/2022SE |
| K213191 | S-LineLGZ · Traditional | Barkey GmbH & Co. KG | 05/24/2022SE |
| K192325 | Quantum Blood and Fluid Warming SystemLGZ · Special | Life Warmer, Inc. | 10/18/2019SE |
| K180842 | MAC Medical D-Series Blanket and Solution Warming CabinetsLGZ · Traditional | Mac Medical, Inc. | 03/05/2019SE |
| K181775 | Quantum Blood and IV Fluid Infusion WarmerLGZ · Traditional | Life Warmer, Inc. | 01/28/2019SE |
| K180154 | QiF Blood and Fluid WarmerLGZ · Special | Quality IN Flow , Ltd. | 04/27/2018SE |
| K171215 | QiF Blood and Fluid WarmerLGZ · Traditional | Quality IN Flow , Ltd. | 09/27/2017SE |
| K163708 | QiF Blood and Fluid WarmerLGZ · Special | Quality IN Flow , Ltd. | 04/20/2017SE |
| K161613 | Hang&Go PACLGZ · Traditional | Rand S.R.L. | 12/28/2016SE |
| K150404 | QiF Blood and Fluid WarmerLGZ · Traditional | Quality IN Flow , Ltd. | 06/23/2016SE |
| K152208 | The Belmont Hyperthermia PumpLGZ · Special | Belmont Instrument Corporation | 09/02/2015SE |
| K150484 | Penguin In-Line WarmerLGZ · Traditional | Creche Innovations | 07/09/2015SE |
| K132202 | DC Series Fluid Warming Cabinet, DC Series Fluid Warming CabinetLGZ · Traditional | Enthermics Medical Systems, Inc. | 12/06/2013SE |
| K131519 | Belmont Hyperthermia PumpLGZ · Special | Belmont Instrument Corp. | 11/06/2013SE |
| K132110 | Natus Warmette Blanket and Dual CabinetsLGZ · Traditional | Natus Nicolet Ireland, Ltd. | 10/03/2013SE |
| K130867 | Enflow IV Fluid Warmer Insulated StrapLGZ · Special | Vital Signs, Inc., A GE Healthcare Company | 06/14/2013SE |
| K122449 | Enteral Nutrition WarmerLGZ · Traditional | Acacia, Inc. | 06/13/2013SE |
| K121775 | Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerLGZ · Special | Vital Signs, Inc., A GE Healthcare Company | 11/28/2012SE |
| K121198 | BW685, BW685SLGZ · Traditional | Biegler GmbH | 07/12/2012SE |
| K120860 | Infu Box Type 0412ALGZ · Traditional | Medical Rescue Equipment Holding AS | 05/08/2012SE |
| K120026 | Performer Ht/ Hang&Go HT BasicLGZ · Traditional | Rand S.R.L. | 05/08/2012SE |
| K112702 | Imperial Surgical Ltd. Blankey and Solution Warning CabinetsLGZ · Traditional | Imperial Surgical , Ltd. | 03/29/2012SE |
| K102900 | Heiter 3000 Hyperthermic Perfusion SystemLGZ · Traditional | Hei, Inc. | 03/21/2012SE |
| K112902 | Enflow IV Fluid WarmerLGZ · Traditional | Vital Signs, Inc. | 03/14/2012SE |
| K111870 | Amsco Warming CabinetLGZ · Special | STERIS Corporation | 07/29/2011SE |
| K110769 | Amsco Warming CabinetLGZ · Special | STERIS Corporation | 06/03/2011SE |
| K103801 | Hypothermx Intravenous Fluid WarmerLGZ · Traditional | Emit Corporation | 05/20/2011SE |
| K091336 | Ivnow Modular Fluid Warmer, 120V, Model IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, Ivnow…LGZ · Traditional | Enthermics Medical Systems, Inc. | 05/07/2010SE |
| K092366 | TTS100 Portable Hyperthermic Perfusion DeviceLGZ · Traditional | Thermal Therapeutic Systems, Inc. | 03/04/2010SE |
| K092823 | Amsco Warming CabinetLGZ · Traditional | STERIS Corporation | 12/18/2009SE |
| K090089 | Belmont Hyperthermia PumpLGZ · Special | Belmont Instrument Corp. | 02/12/2009SE |
| K082765 | Astoflo PlusLGZ · Traditional | Stihler Electronic GmbH | 12/18/2008SE |
| K082217 | Ranger Rapid Flow Blood/Fluid Warming SystemLGZ · Traditional | Arizant Healthcare, Inc. | 10/06/2008SE |
| K072080 | Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…LGZ · Traditional | Smiths Medical Asd, Inc. | 06/02/2008SE |
| K073363 | Thermostat 900 Administration Set, Model Ash 100, 200 and 300LGZ · Traditional | Paladin Biomedical Corporation | 03/20/2008SE |
| K062644 | Flexwarmer, Models KZ-1 and KZ-2LGZ · Traditional | Merlyn Associates, Inc. | 09/11/2007SE |
| K070654 | Hyperthermia PumpLGZ · Traditional | Belmont Instrument Corp. | 06/08/2007SE |
| K060851 | Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the…LGZ · Traditional | The Smithworks Company | 12/22/2006SE |
| K052055 | Smisson-Cartledge Thermal Infusion System, Model TIS-1200LGZ · Traditional | Smisson-Cartledge Biomedical, LLC | 10/26/2006SE |
| K060939 | Ranger Irrigation Fluid Warming SystemLGZ · Traditional | Arizant Healthcare, Inc. | 06/26/2006SE |
| K060537 | Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow Ac…LGZ · Traditional | Enginivity, LLC | 06/08/2006SE |
| K041839 | 8NONELGZ · Traditional | Medical Solutions, Inc. | 02/15/2005SE |
| K032778 | Large Volume Fluid ReservoirLGZ · Special | Belmont Instrument Corp. | 09/22/2003SE |
| K032674 | Belmont Fluid Management System, Model FMS2000LGZ · Special | Belmont Instrument Corp. | 09/16/2003SE |
| K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712LGZ · Traditional | Minimed, Inc. | 07/23/2003SE |
| K024373 | Modification to Animec, Models AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5LGZ · Special | Elltec Co., Ltd. | 01/28/2003SE |
| K023653 | Maxone IV Fluid/Blood Warmer, Model 102LGZ · Traditional | Automatic Medical Technologies, Inc. | 01/17/2003SE |
| K012832 | Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable…LGZ · Traditional | Nxstage Medical, Inc. | 10/24/2001SE |
| K012906 | Animec, Models AM-2S-4 and AM-2S-5LGZ · Special | Elltec Co., Ltd. | 10/09/2001SE |
| K012276 | Temp 3LGZ · Traditional | Medical Solutions, Inc. | 08/20/2001SE |
| K002409 | Maxone, Blood, Blood Products and IV Fluid WarmerLGZ · Traditional | Automatic Medical Technologies, Inc. | 06/28/2001SE |
| K001764 | Hotline 2 Fluid WarmerLGZ · Traditional | Sims Level 1, Inc. | 08/09/2000SE |
| K981509 | Tempo IIILGZ · Traditional | Medical Products, Inc. | 07/10/1998SE |
| K980086 | Heat StackLGZ · Traditional | Medical Solutions, Inc. | 03/10/1998SE |
| K973748 | Tempo and Temp H20LGZ · Traditional | Smith | 03/10/1998SE |
| K954769 | Biegler BW385L Blood & Infusion WarmerLGZ · Traditional | Biegler Medical Products, Inc. | 08/08/1996SE |
| K955659 | DrugboxLGZ · Traditional | C.F. Electronics, Inc. | 05/14/1996SE |
| K922786 | Therm O Drug Model HT-747LGZ · Traditional | C.F. Electronics, Inc. | 01/27/1993SE |
| K914867 | QWIK-1(TM) In-Line IV Fluid WarmerLGZ · Traditional | Microwave Medical Systems, Inc. | 10/23/1992SE |
| K914364 | Astotherm Ift 250, Ift 260, Astotube Various No.LGZ · Traditional | North American Technical Services Corp. | 09/10/1992SE |
| K921395 | Hot SackLGZ · Traditional | C.F. Electronics, Inc. | 09/02/1992SE |
| K911383 | Hotline Fluid WarmerLGZ · Traditional | Level 1 Technologies, Inc. | 10/17/1991SE |
| K904252 | HeatwaveLGZ · Traditional | Medadvances, Inc. | 10/15/1990SE |
| K896018 | BiotempLGZ · Traditional | Medadvances, Inc. | 02/09/1990SE |
| K883873 | Infusion Fluid WarmerLGZ · Traditional | Pmt Corp. | 02/28/1989SE |
| K882361 | Stihler Astotherm Ift 200, Ift 220LGZ · Traditional | Stihler Electronic, C/O Worldwide Regul. Services | 08/25/1988SE |
| K822098 | BT 794-BLOOD/FLUID WarmerLGZ · Traditional | Electromedics, Inc. | 08/20/1982SE |
| K813161 | Flo Tem II (Blood/Fluid WarmerLGZ · Traditional | Datachem, Inc. | 12/09/1981SE |
| K803249 | Fluid WarmerLGZ · Traditional | Datachem, Inc. | 05/21/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2759-2026 Class II | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous…ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid… | ICU Medical Inc. | 06/24/2026Open, Classified |
| Z-2231-2025 Class II | 3M Ranger Irrigation Fluid Warming Set, REF 24750Notice was issued to clarify flow rates related to the inlet fluid temperature. | 3M Company | 04/22/2025Open, Classified |
| Z-1678-2025 Class II | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032…Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a… | Belmont Instrument LLC | 03/31/2025Open, Classified |
| Z-1676-2025 Class II | Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile…Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid… | Belmont Instrument LLC | 03/31/2025Open, Classified |
| Z-1675-2025 Class II | Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use…Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid… | Belmont Instrument LLC | 03/31/2025Open, Classified |
| Z-1674-2025 Class II | Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use…Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid… | Belmont Instrument LLC | 03/31/2025Open, Classified |
| Z-2377-2021 Class I | NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500…There is potential for harmful levels of aluminum leaching when using lower flow rates with certain… | Smiths Medical ASD Inc. | 08/06/2021Open, Classified |
| Z-2376-2021 Class I | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129There is potential for harmful levels of aluminum leaching when using lower flow rates with certain… | Smiths Medical ASD Inc. | 08/06/2021Open, Classified |
| Z-2005-2021 Class I | Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN:…The patient may be exposed to potential aluminum ion release during warming therapy under certain use… | Eight Medical International BV | 06/04/2021Terminated |
| Z-2049-2021 Class II | Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length:…The sterilization contractor informed the company of a quality issue possibly affecting the sterilization… | RanD S.r.l. | 04/30/2021Terminated |
| Z-2048-2021 Class II | Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120The sterilization contractor informed the company of a quality issue possibly affecting the sterilization… | RanD S.r.l. | 04/30/2021Terminated |
| Z-1260-2021 Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Customers are being notified of results from a Toxicological Risk Assessment related to potential for… | Smisson-Cartledge Biomedical, LLC | 02/18/2021Terminated |
| Z-1259-2021 Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Customers are being notified of results from a Toxicological Risk Assessment related to potential for… | Smisson-Cartledge Biomedical, LLC | 02/18/2021Terminated |
| Z-1258-2021 Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor…Customers are being notified of results from a Toxicological Risk Assessment related to potential for… | Smisson-Cartledge Biomedical, LLC | 02/18/2021Terminated |
| Z-1386-2019 Class I | enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy…Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. | Vyaire Medical | 03/13/2019Terminated |
| Z-1385-2019 Class I | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood…Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. | Vyaire Medical | 03/13/2019Terminated |
| Z-1145-2017 Class III | HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid…HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish… | Smiths Medical ASD, Inc. | 10/31/2016Terminated |
| Z-0951-2017 Class II | Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket…The fuse blows during initial power up or after a period of time. This results in a complete loss of power… | Natus Manufacturing Limited | 10/15/2016Terminated |
| Z-0603-2016 Class II | AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of…The firm discovered that information printed on the quick reference magnet is incorrect; specifically… | Steris Corporation | 11/20/2015Terminated |
| Z-1444-2014 Class II | Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery…Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may… | Smiths Medical ASD, Inc. | 03/17/2014Terminated |
| Z-1443-2014 Class II | Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery…Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may… | Smiths Medical ASD, Inc. | 03/17/2014Terminated |
| Z-1979-2012 Class II | Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage:…HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the… | Smiths Medical ASD, Inc. | 06/27/2012Terminated |
| Z-1972-2012 Class II | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE…The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for… | Vital Signs Devices, a GE Healthcare Company | 02/20/2012Terminated |
| Z-0428-2012 | Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0427-2012 | Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0426-2012 | HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0425-2012 | HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0424-2012 | HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0423-2012 | HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-0422-2012 | HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient…Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable… | Smiths Medical ASD, Inc. | 11/21/2011Terminated |
| Z-3040-2011 | enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model…enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the… | Vital Signs Devices, a GE Healthcare Company | 06/30/2011Terminated |
| Z-2380-2010 | Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical…The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not… | Vital Signs Inc | 07/15/2010Terminated |
| Z-2008-2009 | Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154…1. Fluid contamination of the electronic circuitry can cause short circuits resulting in permanent fuse… | Enginivity LLC | 03/23/2009Terminated |