Recipient:Cincinnati Sub-Zero Products, Inc. Product:Blanketrol II, Blanketrol III, Electri-Cool II, Micro-Temp LT, Hemotherm, Norm-O-Temp, Extra Corporeal Membrane Oxygenation Blood Temperature Control System, and Warm Air Hyperthermia System Date:12/13/2010 Failure to establish and maintain adequate procedures for validating the device design, including software, to ensure that devices conform to user needs and intended uses and include...Read More