Cincinnati Sub-Zero Hemotherm 400CE Water Flow and Temperature Control Recall
Cincinnati Sub-Zero is recalling 50 Hemotherm 400CE devices because they may fail to maintain water flow or temperature control.
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 3/5 (High).
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 the hazard involves a medical device failing to maintain temperature control, which poses a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Cincinnati Sub-Zero Products Inc is recalling 50 units of the Hemotherm 400CE 115v, containing power board p/n 39945. The recall is due to a defect where the device may not maintain water flow or temperature control.
The affected devices were distributed in the United States to the states of California, Florida, Georgia, Massachusetts, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania, and South Carolina. Specific serial codes for the affected units are listed in the official recall documentation.
Consumers who possess these devices should stop using them and contact Cincinnati Sub-Zero Products Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- The Hemotherm 400CE 115v, containing power board p/n 39945
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Affected units
- 50
Distribution
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