Cincinnati Sub-Zero Products recalls Norm-O-Temp 111Z devices that may cause tissue damage if overheated beyond 40°C for extended periods. Affected units have specific serial numbers and part numbers.
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Cincinnati Sub-Zero Products is recalling Norm-O-Temp 111Z devices because their manual doesn't warn that overheating above : 40°C for long periods can damage tissue. This is a safety issue for people using these devices in medical settings.
The device's manual fails to state that prolonged exposure to temperatures over 40°C can cause tissue damage. This means users might not know when overheating could harm their skin or tissues.
Users of Norm-O-Temp 111Z devices in medical settings are most at risk. The recall affects specific serial numbers and part numbers.
Check for the Norm-O-Temp 111Z model with serial numbers starting with 113-0001N-192-0798N and part numbers 86153 or 86154. These units were sold with specific UDI codes.
Identify your Norm-O-Temp 111Z model using the serial numbers or part numbers listed in the recall notice.
The recall is because the manual does not warn that prolonged exposure to temperatures over 40°C can cause tissue damage.
The recall does not specify a remedy, so there is no action required beyond checking if your device matches the described serial numbers or part numbers.
The product could cause tissue damage if overheated beyond 40°C for extended periods, but the recall does not indicate immediate danger for most users.
We’ve drafted a message you can send Sub-Zero to request your refund or repair — edit it as you like.
Subject: Recall Z-2355-2019 — Sub-Zero Sub-Zero Hello, I own a Sub-Zero that is covered by recall Z-2355-2019 from 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.
