FDA Device recall Z-0825-2019
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used t…
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used t… by Cincinnati Sub Zero Products A Gentherm, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0825-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-19 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cincinnati Sub Zero Products A Gentherm |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial numbers 151-10283CE through 171-10721CE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2019%22
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