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    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·December 28, 2012

    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·December 28, 2012

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    FDA Recall
    Terminated ·Miramar Labs, Inc.·Product code OUB·October 9, 2015

    MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs, Inc. 445 Indio Way Sunnyvale, CA 94085 Intended use: Treatment of primary axillary hyperhidrosis.

    FDA Recall
    Terminated ·Miramar Labs, Inc.·Product code OUB·April 24, 2011

    Warm Air Model 135 Warming Units.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products·Product code BTE·November 5, 2004

    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

    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

    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

    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 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 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

    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

    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

    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