Hemotherm 400CE Recalled for Control Panel Switch Errors
Cincinnati Sub-Zero is recalling 270 Hemotherm 400CE devices due to potential control panel switch errors that may prevent setting changes or cause unintended changes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cincinnati Sub-Zero Products LLC, a Gentherm Company, is recalling 270 units of the Hemotherm 400CE Dual Reservoir Cooler/Heater (Catalog Numbers 86022 & 86023). The devices are used to control water temperature for blood oxygenators during cardiopulmonary bypass procedures or for patient warming via hyper/hypothermia blankets.
The recall is due to a potential for membrane (control panel) switch errors. These errors could lead to an inability of the device to change control settings or an unintended change to control settings. The recall is classified as Class II by the FDA.
The affected units were distributed nationwide in the United States. Users should contact the recalling firm for instructions on how to proceed with the recall.
The recalled product
- 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 pr
- Affected units
- 270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 10613031860221
Distribution
Distributed nationwide across the United States.
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