CritiCool Thermoregulation Device Recalled Due to Pump Failure
The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text reports one death potentially related to this device failure. Per the severity rubric, the presence of reported deaths triggers a Critical (5) classification regardless of other factors.
Plain-English summary
Belmont Instrument Corporation is recalling the CritiCool thermoregulation device used to deliver thermoregulation therapy. The recall affects 158 units distributed in the United States and 803 units distributed internationally.
The device may experience premature pump failure that triggers a HALT 4 error. Once this error occurs, the device cannot recover from it even after a reboot, preventing delivery of the prescribed thermoregulation therapy and potentially delaying critical treatment.
One death has been reported that may potentially be related to this device failure. Healthcare providers using the CritiCool device should verify whether they have affected units and contact Belmont Instrument Corporation for guidance.
The recalled product
- Product
- CritiCool, thermoregulation device
- Manufacturer
- Belmont Instrument Corporation
Distribution
Distributed nationwide across the United States.
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