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Cincinnati Sub-Zero Products Inc recalls 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or mai
Recalled June 11, 2014 · FDA recall Z-1679-2014 · Cincinnati Sub-Zero Products
Hazard
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 · FDA Class II
Units
7 units
Sold at
The product was distributed to one customer in MI, and internationally (Taiwan)
Description
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
Product
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.
Manufacturer(s)
Cincinnati Sub-Zero Products Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →