126 results
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150ms
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Sources: EU EUDAMED, US FDA
BLANKETROL LLL
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·May 12, 2021
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 Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013
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
*
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC·Product code DWJ·April 12, 2010
WARM AIR
FDA Adverse Event
CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·June 1, 2010
KOOL KIT
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·June 15, 2010
NORM-O-TEMP / MAXI-THERM LITE BLANKET
FDA Adverse Event
Injury
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·June 19, 2014
MAXI THERM LITE BLANKET FOR BLANKETROL III
FDA Adverse Event
Malfunction
·CINCINNATI SUB ZERO PRODUCTS, INC.·Product code DWJ·October 2, 2017
SMART HYPER-HYPOTHERMIA
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·December 21, 2017
ECMO-HEATER
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·April 4, 2012
BLANKETROL III
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·October 2, 2017
HEMOTHERM
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·January 6, 1994
HEMOTHERM
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS INC.·Product code DWJ·May 17, 2000
MAXI-THERM
FDA Adverse Event
Injury
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·June 20, 2007
*
FDA Adverse Event
CINCINNATI SUB-ZERO PRODUCTS, INC·Product code DWC·May 22, 2007
MAXI-THERM
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC·Product code DWJ·December 12, 2007
BLANKETROL III
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·December 21, 2017
COLD THERAPY PAD
FDA Adverse Event
Malfunction
·CINCINNATI SUB-ZERO PRODUCTS, INC.·Product code DWJ·October 28, 2010