Hemotherm CE Dual Reservoir Cooler/Heater — Class II medical device recall Z-0825-2019
Terminated recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, reported 2019-02-20, distributed nationwide. Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the f
| Recall number | Z-0825-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH, United States |
| Recall initiated | 2018-12-19 |
| Classified | 2019-02-13 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 396 |
| Reason classes | device malfunction |
| Serial numbers | 151-10283CE |
| Model numbers | 400CE |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0825-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.