Reported Jun 11, 2014 · Terminated
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or…
Cincinnati Sub-Zero Products Inc.
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 Inc · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
- Lot codes and dates
Model Number 222SSerial #s: 133-2-00697133-2-00698133-2-00699133-2-00700133-2-00701133-2-00702
- and 133-2-00703Part # 86165
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
This product could cause temporary or reversible health problems — stop using it.
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