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Cincinnati Sub-Zero Products Recalls
7 recalls on record · September 25, 2013 to February 21, 2018 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 21, 2018Medical DevicesFDA
Cincinnati Sub-Zero Products LLC recalls Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circul
Hazard: Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.
April 26, 2017Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls Hemotherm CE, model 400CE, Heater-Cooling Device
Hazard: Improperly rated fuses were used in the manufacture of the device.
November 30, 2016Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls The Hemotherm 400CE 115v, containing power board p/n 39945
Hazard: The device may not maintain water flow or temperature control.
February 25, 2015Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local
Hazard: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
June 11, 2014Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or mai
Hazard: The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
December 11, 2013Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the e
Hazard: During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer.
September 25, 2013Medical DevicesFDA
Cincinnati Sub-Zero Products Inc recalls Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hype
Hazard: During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.