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U.S. Department of Health and Human Services

Class 2 Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System

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  Class 2 Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System see related information
Date Initiated by Firm January 08, 2014
Date Posted June 10, 2014
Recall Status1 Terminated 3 on June 06, 2014
Recall Number Z-1679-2014
Recall Event ID 68356
510(K)Number K110104  
Product Classification Thermal regulation System - Product Code DWJ
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact Mrs. Kolleen M. Tener
513-772-8810 Ext. 5295
Manufacturer 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
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax
Quantity in Commerce 7 units
Distribution The product was distributed to one customer in MI, and internationally (Taiwan)
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.
510(K) Database 510(K)s with Product Code = DWJ and Original Applicant = CINCINNATI SUB-ZERO PRODUCTS, INC.
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