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    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DWC·November 13, 2015

    Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicated for controlling and monitoring patient temperature.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016

    Hemotherm CE, model 400CE, Heater-Cooling Device

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWC·March 9, 2017

    STOCKERT Heater-Cooler System 3T, 208V/60 Hz

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·June 30, 2017

    STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·June 30, 2017

    Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DWC·September 27, 2016

    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWC·December 19, 2018

    CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine

    FDA Recall
    Terminated ·MAQUET Inc.·Product code DWC·November 10, 2006

    Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC·Product code DWC·November 27, 2017

    Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitoring patient temperature.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016

    Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWC·September 4, 2018

    CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 24, 2023

    The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. The Sarns" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia. Device Name / Model Number: TCM II, with Cardioplegia, 110V/60Hz (P/N 164925) TCM II, without Cardioplegia, 110V/60Hz (P/N 164930) TCM II, with Cardioplegia, 220V/50Hz (P/N 164935) TCM II, without Cardioplegia, 220V/50Hz (P/N 164940) TCM (P/N 15747) Catalog Number: 4415, 164925, 164930, 164935, 15747

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·April 16, 2021

    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code DWC·July 14, 2021

    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·October 16, 2012

    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·August 15, 2012

    STOCKERT Heater-Cooler System 3T, 240V/60 Hz

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWC·June 30, 2017

    CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·May 12, 2021

    CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

    FDA Recall
    Open, Classified ·CardioQuip, LLC·Product code DWC·October 19, 2023