The Hemotherm 400CE 115v, containing power board p/n 39945
FDA Device Recall #Z-0654-2017 — Class II — November 7, 2016
Recall Summary
| Recall Number | Z-0654-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 7, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cincinnati Sub-Zero Products Inc |
| Location | Cincinnati, OH |
| Product Type | Devices |
| Quantity | 50 |
Product Description
The Hemotherm 400CE 115v, containing power board p/n 39945
Reason for Recall
The device may not maintain water flow or temperature control.
Distribution Pattern
US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Lot / Code Information
154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE
Other Recalls from Cincinnati Sub-Zero Products Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1825-2017 | Class II | Hemotherm CE, model 400CE, Heater-Cooling Device | Mar 9, 2017 |
| Z-1129-2015 | Class II | Cold Therapy Pad - cold water circulating pad, ... | Jan 7, 2015 |
| Z-1679-2014 | Class II | 115 V Blanketrol II, Model 222S Hyper-Hypotherm... | Jan 8, 2014 |
| Z-2209-2013 | Class II | Blanketrol III, Model Number 233, Cincinnati Su... | Sep 3, 2013 |
| Z-0443-2014 | Class II | Blanketrol III Data Export Software Version 1.1... | May 15, 2013 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.