Reported Nov 27, 2019 · Terminated
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The system is composed of…
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cincinnati Sub-Zero Products LLC, a Gentherm Company · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- CoolBlue Hyper-Hypothermia
- System- body hypothermia system ModelInnercool -
- Product UsageThe system is composed of a heater, a compressor, a circulating pump and blankets/pads
- Lot codes and dates
- Serial Numbers073-CB-00001 through 162-CB-00294
- Amount recalled
- 5291
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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