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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K101589
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Product Description
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FDA Recall
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Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 ... 2 11/18/2019 Cincinnati Sub-Zero Products LLC, a Gentherm Company
CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product Usage: The sy... 2 11/18/2019 Cincinnati Sub-Zero Products LLC, a Gentherm Company
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinna... 2 09/16/2013 Cincinnati Sub-Zero Products Inc
115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model ... 2 03/30/2011 Cincinnati Sub-Zero Products Inc
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