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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description 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.
Recall Number Z-1679-2014
Classification Class II
Code Info Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165
Product Distributed Qty 7 units
Reason For Recall 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 no alarms will alert the user of the loss of therapy condition.

Event Detail

Event Id 68356
Product Type Devices
Status Terminated
Recalling Firm Cincinnati Sub-Zero Products Inc
City Cincinnati
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-08
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern The product was distributed to one customer in MI, and internationally (Taiwan)