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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
Recall Number Z-2209-2013
Classification Class II
Code Info Part number: 86107/06107/6107 (115V), Serial #s: 112-3-02021, 112-3-02102 through 124-3-02783, 074-3-00388, 081-3-00489, 081-3-00493, 082-3-00511, 091-3-00935, 094-3-01261, 094-3-01265, 094-3-01272, 094-3-01304, 094-3-01308, 101-3-01384, 093-3-01045, 093-3-01046, 093-3-01069, 084-3-00775, 073-3-00315, 091-3-00918, 091-3-00919, 073-3-00279, 094-3-01262, 071-3-00183, 092-3-00983, 094-3-01255, 064-3-00114, 072-3-00219, 072-3-00222, 072-3-00230, 072-3-00258, 081-3-00499, 081-3-00500, 064-3-00116, 064-3-00117, 092-3-01021, 073-3-00305, 073-3-00314, 082-3-22572, 082-3-22573, 101-3-01380, 073-3-00317, 074-3-00341, 091-3-00932, 094-3-01310, 101-3-01374, 082-3-00559, 092-3-00983, 094-3-01255, 094-3-01305, 062-3-00029, 093-3-01048, 094-3-01240, 102-3-01504 & 094-3-01243. Part number: 86207/6207 (230V) Serial #s: 112-3-01949, 114-3-02171 through 124-3-02764, 072-3-00247, 073-3-00266, 073-3-00282, 082-3-00564, 071-3-00132, 071-3-00152, 073-3-00309, 082-3-00533, 082-3-00534, 082-3-00565, 082-3-00568, 084-3-00768, 084-3-00770, 084-3-00777, 084-3-00778, 084-3-00779, 084-3-00780, 084-3-00781, 084-3-00787, 084-3-00788, 091-3-00836, 091-3-00877, 091-3-00878, 091-3-00902, 092-3-01007, 092-3-01008, 092-3-01011, 102-3-01423, 102-3-01426, 103-3-01592, 103-3-01593, 103-3-01594, 103-3-01595, 103-3-01601, 093-3-01072, 093-3-01073, 093-3-01076, 093-3-01078, 093-3-01084, 093-3-01085, 093-3-01086, 093-3-01087, 093-3-01088, 093-3-01104, 093-3-01105, 093-3-01106, 093-3-01107, 093-3-01108, 103-3-01573, 103-3-01574, 103-3-01575, 071-3-00178, 071-3-00180, 074-3-00393, 074-3-00394, 074-3-00395, 074-3-00396, 074-3-00404, 074-3-00405, 091-3-00904, 091-3-00905, 092-3-00939, 092-3-00948, 092-3-00949, 092-3-00951, 092-3-00962, 092-3-00963, 094-3-01178,094-3-01179, 094-3-01180, 094-3-01181, 094-3-01183, 084-3-00789, 084-3-00790, 084-3-00791, 084-3-00812, 084-3-00813, 084-3-00814, 084-3-00815 & 084-3-00816.
Product Distributed Qty 115V - 396 units; 230V - 385 units
Reason For Recall During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.

Event Detail

Event Id 66155
Product Type Devices
Status Ongoing
Recalling Firm Cincinnati Sub-Zero Products Inc
City Cincinnati
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM.
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