Warmer, Thermal, Infusion Fluid
General Hospital · 21 CFR 880.5725
Recent MDR events
6,999 adverse event reports on file
- Level 1 Low Flow Hotline Disposable Injection SetJul 28, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.2025816-2026-00012
- AmscoJul 27, 2026MalfunctionSteris Corporation1043572-2026-00072
- RAPID INFUSER RI-2, 120V, 750 ML/MINJul 21, 2026MalfunctionBelmont Instrument Llc25888846
- Belmont Rapid Infuser RI-2Jul 20, 2026OtherMW6000052
- Level 1 Mass TransfuserJul 18, 2026OtherMW6000036
- Level 1 Mass TransfuserJul 18, 2026OtherMW6000037
- ENFLOWJul 12, 2026InjuryAirlife Oy3010838917-2026-00005
- LEVEL 1 HOTLINE FLUID WARMER, 230 V ITALIAN MODELJul 8, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v3012307300-2026-07229
- CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINEJul 7, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v3012307300-2026-07109
- LEVEL 1 LOW FLOW HOTLINE DISPOSABLE SETJul 7, 2026MalfunctionIcu Medical Healthcare Manufacturing S.a. De C.v.3012307300-2026-07138
Event type breakdown
Recalls
33 recall events for this product code
- ICU Medical Inc.Open, ClassifiedJul 17, 2026
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at norm
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
Z-2759-2026 · View FDA record ↗ - 3M CompanyOpen, ClassifiedAug 1, 2025
3M Ranger Irrigation Fluid Warming Set, REF 24750
Notice was issued to clarify flow rates related to the inlet fluid temperature.
Z-2231-2025 · View FDA record ↗ - Belmont Instrument LLCOpen, ClassifiedApr 25, 2025
Hyperthermia Pump Procedure Kit. Model Number: 902-00045.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Z-1674-2025 · View FDA record ↗ - Belmont Instrument LLCOpen, ClassifiedApr 25, 2025
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Z-1675-2025 · View FDA record ↗ - Belmont Instrument LLCOpen, ClassifiedApr 25, 2025
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038.
Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
Z-1676-2025 · View FDA record ↗ - Belmont Instrument LLCOpen, ClassifiedApr 25, 2025
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032.
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
Z-1678-2025 · View FDA record ↗ - Smisson-Cartledge Biomedical, LLCTerminatedMar 26, 2021
ThermaCor 1200 Disposable Sets
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Z-1258-2021 · View FDA record ↗ - Smisson-Cartledge Biomedical, LLCTerminatedMar 26, 2021
ThermaCor 1200 Disposable Sets
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Z-1259-2021 · View FDA record ↗ - Smisson-Cartledge Biomedical, LLCTerminatedMar 26, 2021
ThermaCor 1200 Disposable Sets
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.
Z-1260-2021 · View FDA record ↗ - Vyaire MedicalTerminatedJun 26, 2019
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming.
Z-1385-2019 · View FDA record ↗
Registered firms
114 firms currently registered for this product code
Belmont Medical Technologies
BILLERICA, MA, US
Medical Solutions, Inc.
CHANTILLY, VA, US
Rand S.p.a.
MEDOLLA Modena, IT
Cbr Enterprise Limited
Hong Kong, HK
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Lynx Medical Pennsylvania
ERIE, PA, US
The Surgical Company International B.v.
Amsterdam Noord-Holland, NL
Garrett Heilbrun Technology Partners, Llc Dba Cobalt Product Solutions
Plano, TX, US
Beldico S.a.
Marche-en-Famenne Luxembourg, BE
Sterox Srl
Filago Bergamo, IT
Mfg One, Llc
CHANTILLY, VA, US
Ecm Europe Bv
Gemert Noord-Brabant, NL
Isomedix Operations Inc.
SAN DIEGO, CA, US
Medimexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Steripack Asia Sdn Bhd
Klang Selangor, MY
Solventum Us Llc
San Antonio, TX, US
Stryker Endoscopy
SAN JOSE, CA, US
Provita Medical Gmbh & Co. Kg
WERMELSKIRCHEN North Rhine-Westphalia, DE
Tribalco
Tampa, FL, US
510(k) clearances
75 clearances for this product code
- Mequ A/SApr 24, 2026
K260988 · °M Warmer System with °M Station
- The Surgical Company International B.V.Nov 18, 2025
K252636 · Fluido Compact System
- The Surgical Company International BV (As Tsc Life)Sep 4, 2025
K251733 · Fluido® AirGuard System
- Mequ A/SMay 31, 2024
K232107 · °M Warmer System
- The Surgical Company International B.V.Jun 5, 2023
K211618 · Fluido Compact Blood and Fluid Warming System
- Quality IN Flow , Ltd.Dec 8, 2022
K211800 · Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
- Smisson-Cartledge Biomedical, LLCAug 12, 2022
K202461 · ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
- Barkey GmbH & Co. KGMay 24, 2022
K213191 · S-Line