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Companies / Cincinnati Sub-Zero Products LLC, a Gentherm Company
Cincinnati Sub-Zero Products LLC, a Gentherm Company
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2291-2019 | Class III | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body | July 19, 2019 |
| Z-0418-2020 | Class II | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is compose | July 2, 2019 |
| Z-0419-2020 | Class II | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The sy | July 2, 2019 |
| Z-0417-2020 | Class II | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 | July 2, 2019 |
| Z-2355-2019 | Class II | Norm-O-Temp model 111Z | June 20, 2019 |
| Z-2356-2019 | Class II | Norm-O-Temp model 111W | June 20, 2019 |
| Z-0825-2019 | Class II | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 4 | December 19, 2018 |
| Z-0063-2019 | Class II | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is | September 4, 2018 |