18 results
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63ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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 Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC·February 21, 2018
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
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
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
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code ILO·July 19, 2019
Norm-O-Temp model 111Z
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019
Norm-O-Temp model 111W
FDA Recall
Terminated
·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·June 20, 2019
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 Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·October 10, 2018
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 Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·February 20, 2019
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
FDA Enforcement
Class III
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·August 28, 2019
Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·November 27, 2019
Norm-O-Temp model 111Z
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·September 11, 2019
Norm-O-Temp model 111W
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC, a Gentherm Company·September 11, 2019