Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Mode...
FDA Device Recall #Z-0825-2019 — Class II — December 19, 2018
Recall Summary
| Recall Number | Z-0825-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 19, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company |
| Location | Cincinnati, OH |
| Product Type | Devices |
| Quantity | 396 |
Product Description
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through conductive heat transfer.
Reason for Recall
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The products were distributed to the following foreign countries: Columbia and Taiwan.
Lot / Code Information
Serial numbers 151-10283CE through 171-10721CE
Other Recalls from Cincinnati Sub-Zero Products LLC, a G...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2291-2019 | Class III | MICRO-TEMP LT System, Model 749- Localized Heat... | Jul 19, 2019 |
| Z-0419-2020 | Class II | CoolBlue Hyper-Hypothermia System- body hypothe... | Jul 2, 2019 |
| Z-0417-2020 | Class II | Blanketrol III Hyper-Hypothermia System- body h... | Jul 2, 2019 |
| Z-0418-2020 | Class II | Blanketrol II Hyper-Hypothermia System, Models... | Jul 2, 2019 |
| Z-2355-2019 | Class II | Norm-O-Temp model 111Z | Jun 20, 2019 |
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.