Cincinnati Sub-Zero recalls two models of hyper-hypothermia systems due to risk of tissue damage from overheating beyond 40°C. Affected units include specific model ranges sold between certain dates.
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 two models of hyper-hypothermia systems because they can cause tissue damage if overheated beyond 40°C. This risk occurs when the device runs at temperatures that exceed safe limits for extended periods.
The system can overheat if it runs at temperatures above 40°C for extended periods, potentially causing tissue damage. The device includes warnings about temperature limits but may not be used correctly, leading to unsafe conditions.
Users of the Blanketrol II Hyper-Hypothermia System models 222R and 222S are affected. People using the system for medical purposes, particularly those with low body temperature, are most at risk.
Check for model numbers 222R (071-18490 through 123-20534) or 222S (104-2-00001 through 161-2-01848) on the product. These models were sold with specific serial number ranges.
Ensure the device does not exceed 40°C for extended periods by reviewing the temperature settings and usage guidelines.
Models 222R (071-18490 through 123-20534) and 222S (104-2-00001 through 161-2-01848).
The system can cause tissue damage if it overheats beyond 40°C for extended periods, as stated in the recall notice.
Check the temperature settings to ensure they do not exceed 40°C for extended periods. The recall does not require immediate action beyond this check.
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-0418-2020 — Cincinnati Sub-Zero Cincinnati Sub-Zero Hello, I own a Cincinnati Sub-Zero that is covered by recall Z-0418-2020 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.
