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U.S. Department of Health and Human Services

Class 2 Device Recall HyperHypothermia System

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  Class 2 Device Recall HyperHypothermia System see related information
Date Initiated by Firm October 27, 2011
Date Posted February 07, 2012
Recall Status1 Terminated 3 on February 26, 2013
Recall Number Z-0969-2012
Recall Event ID 60721
Product Classification System, thermal regulating - Product Code DWJ
Product Blanketrol II 48¿C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48¿C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area.

The 48¿C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C.
Code Information Blanketrol ll 48¿C - Models 222 & 222R Hyper-Hypothermia Systems: Serial Numbers: 902-8645, 902-8646, 911-9426, 914-10001, 914-10140, 914-10177, 943-12074, 992-14052, 994-14290, 994-14291, 002-14541, 002-14545, 012-15024, 014-15260, 022-15490, 074-18981, 962-12825, and 874-6277.  
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact Pradeep K. Gupta
513-772-8810
Manufacturer Reason
for Recall		 The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution.
FDA Determined
Cause 2		 Software design
Action CSZ sent an "URGENT: FIELD ACTION NOTICE" letter dated January 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to become familiar with the amended manual page and to get approvals from the Institutional Review Board before further use of the device. Additionally, a response form was enclosed with the letter for customers to complete and return via fax to (513)772-9119. Contact CSZ Service Department at 1-800-989-7373 for questions regarding this notice.
Quantity in Commerce 16 of these devices were distributed in the U.S., and two (2 ) outside the U.S.
Distribution Nationwide Distribution-including the District of Columbia and states of CA, GA, MA, MD, MI, NJ, NY, OH, and UT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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