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    WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·June 1, 2011

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code BZT·September 26, 2011

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011

    FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·November 14, 2009

    TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·November 14, 2009

    ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·May 2, 2011

    ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·May 2, 2011

    Electri-Cool II

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 18, 2005

    Hemotherm CE, model 400CE, Heater-Cooling Device

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

    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 18, 2010

    The Hemotherm 400CE 115v, containing power board p/n 39945

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWS·November 7, 2016

    Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The Hemotherm 48C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48C .

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 27, 2011

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·January 8, 2014

    Micro-temp II heat therapy unit, model #747.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 18, 2005

    Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 7, 2015

    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·May 15, 2013

    Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. The device draws in room air through a filter by means of an electric blower. It heats the air to the desired temperature by controlling the air temperature entering a flexible connecting hose, and conveys it to the disposable blanket (i.e. FilteredFlow Blankets, Warming Tube) in contact with the patient, in order to warm the patient. This device provides a continuous flow of heated air as a means of warming patients suffering the common, but significant problems of hypothermia. The system can be used in Post Anesthesia Care Units (PACUs), Intensive Care Units (ICUs), Surgical Intensive Care Units (SICUs), Emergency Rooms (ERs), Operating Rooms (ORs), or any other departments or hospital facilities requiring patient temperature management.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·May 19, 2011

    Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The 48C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 27, 2011

    WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·February 16, 2009