FDA Device recall Z-0063-2019
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the tempera…
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the tempera… by Cincinnati Sub Zero Products A Gentherm, citing potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0063-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-04 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cincinnati Sub Zero Products A Gentherm |
| Distribution | US |
Product
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ 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
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
Identifiers
| code_info | UDI 10613031860221 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0063-2019%22
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