Cincinnati Sub-Zero Products Inc
Medical device manufacturer in Cincinnati, OH.
12510(k) clearances
0PMA approvals
20recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K123946 | Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsDWJ · Special | 01/17/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | 12/18/2012SE |
| K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets)DWJ · Special | 07/03/2012SE |
| K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/PadsDWJ · Traditional | 02/17/2012SE |
| K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment SystemDWJ · Traditional | 02/04/2011SE |
| K101148 | Warm Air Model 135 Hyperthermia System and BlanketsDWJ · Traditional | 10/01/2010SE |
| K101589 | Blanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsDWJ · Traditional | 09/20/2010SE |
| K072621 | Esophageal/Rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorBZT · Traditional | 12/13/2007SE |
| K070339 | Disposable Temperature Probes/Sensors and Instrument CablesFLL · Traditional | 09/26/2007SE |
| K942790 | Warm Air Hypertheermia System (Models #130 and #133)DWJ · Traditional | 01/24/1995SE |
| K942599 | Warm Air Warming UnitDWJ · Traditional | 01/24/1995SE |
| K910327 | Warmair SystemDWJ · Traditional | 05/16/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0629-2018 Class II | Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A…Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to… | 11/27/2017Terminated |
| Z-1825-2017 Class II | Hemotherm CE, model 400CE, Heater-Cooling DeviceImproperly rated fuses were used in the manufacture of the device. | 03/09/2017Terminated |
| Z-0654-2017 Class II | The Hemotherm 400CE 115v, containing power board p/n 39945The device may not maintain water flow or temperature control. | 11/07/2016Terminated |
| Z-1129-2015 Class II | Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used…Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water… | 01/07/2015Terminated |
| Z-1679-2014 Class II | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a…The incorrect voltage component was placed into the device during manufacturing. This may make the device… | 01/08/2014Terminated |
| Z-2209-2013 Class II | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller…During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations &… | 09/03/2013Terminated |
| Z-0443-2014 Class II | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software…During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was… | 05/15/2013Terminated |
| Z-1656-2012 | ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136…Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located… | 02/03/2012Terminated |
| Z-0970-2012 | Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number:…The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS… | 10/27/2011Terminated |
| Z-0969-2012 | Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R.…The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or… | 10/27/2011Terminated |
| Z-0372-2012 | Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe…Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the… | 09/26/2011Terminated |
| Z-3119-2011 | Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System…Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model… | 07/20/2011Terminated |
| Z-2888-2011 | WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to…Due to its design the circuit breaker on the device could trip causing it to shut down and not provide… | 06/01/2011Terminated |
| Z-2800-2011 | Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing…A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir… | 05/19/2011Terminated |
| Z-2721-2011 | ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is…The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to… | 05/02/2011Terminated |
| Z-2720-2011 | ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is…The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to… | 05/02/2011Terminated |
| Z-1817-2011 | 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V…The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's… | 10/18/2010Terminated |
| Z-0782-2010 | TempPad Cold Therapy Pad. The device is used for localized temperature therapy including…Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging… | 11/14/2009Terminated |
| Z-0781-2010 | FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a…Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging… | 11/14/2009Terminated |
| Z-0035-2010 | WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold…The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and… | 02/16/2009Terminated |