Cincinnati Sub-Zero recalls CoolBlue Hyper-Hypothermia System Model Innercool due to risk of tissue damage from overheating beyond 40°C. Affected units have serial numbers 073-CB-00001 to 162-CB-00294.
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
Cincinnati Sub-Zero is recalling their CoolBlue Hyper-Hypothermia System Model Innercool because it can cause tissue damage if used for extended periods above 40°C. This risk is due to overheating in the system's automatic modes.
The system can overheat if used for extended periods above 40°C, potentially causing tissue damage. The warnings state that exceeding this temperature in automatic modes may lead to injury.
Users of the CoolBlue Hyper-Hypothermia System Model Innercool are affected. People using the system for medical hypothermia treatment are most at risk.
Check for the CoolBlue Hyper-Hypothermia System Model Innercool. Affected units have serial numbers starting with 073-CB-00001 through 162-CB-00294.
Ensure the system does not exceed 40°C for extended periods to prevent tissue damage.
Exceeding 40°C for extended periods may cause tissue damage, especially in automatic modes.
Affected units have serial numbers from 073-CB-00001 to 162-CB-00294.
The recall does not specify a remedy; check temperature settings to avoid overheating.
We’ve drafted a message you can send Cincinnati Sub-Zero to request your refund or repair — edit it as you like.
Subject: Recall Z-0419-2020 — Cincinnati Sub-Zero Cincinnati Sub-Zero Hello, I own a Cincinnati Sub-Zero that is covered by recall Z-0419-2020 from Cincinnati Sub-Zero. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.