Cincinnati Sub-Zero Products Inc: Medical Device Recall in 2013 - (Recall #: Z-2209-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 3, 2013

Date Posted: September 25, 2013

Recall Number: Z-2209-2013

Event ID: 66155

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.

Status: Terminated

Product Quantity: 115V - 396 units; 230V - 385 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated