Z-0969-2012

Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C...

Name: Z-0969-2012 Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2011-10-27
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2011-10-27 / Terminated / root cause: software

FDA source

Cincinnati Sub-Zero Products Inc began a recall of Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled... on 2011-10-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0969-2012
Status: Terminated
Initiated: 2011-10-27
Posted: 2012-02-07
Terminated: 2013-02-26
Recalling firm: Gentherm Medical, LLC
Product: Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C 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 48C 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.
Product code: DWJ System, Thermal Regulating
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 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.

Product code DWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)