Z-2209-2013Class II

Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH...

Name: Z-2209-2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2013-09-03
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2013-09-03 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products Inc began a recall of Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to... on 2013-09-03. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2209-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-03
Posted: 2013-09-16
Terminated: 2014-08-22
Recalling firm: Gentherm Medical, LLC
Product: 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 code: DWJ System, Thermal Regulating
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Cincinnati Sub-Zero (CSZ) sent an Urgent Medical Device Field Action letter dated September 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CSZ at 513-772-8810 or 1-800-989-7373 to request new versions of the manuals. At that time customers are instructed to provide the quantity and serial numbers of the affected devices that are at their facility. Upon receipt of the new versions of the manual, immediately collect and destroy/discard all the affectred devices Operation and Technical Manuals their facility is currentlyin possession of and replace the discarded manuals with the new versions of the manuals provided by CSZ. After the manuals have been discarded and replaced, customers were asked to complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that they have performed and completed the requested actions. Customers should return the form by fax to 513-772-9119 scan and email the information to [email protected] or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, Ohio 45241. Customers with questions were instructed to contact their Blanketrol III Model 233 field action coordinator at 1-800-989-7373 or 513-772-8810. For questions regarding this recall call 513-772-8810, ext 5295.
Quantity in commerce: 115V - 396 units; 230V - 385 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2209-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2209-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-16

Product code DWJ

K101589Class IIBlanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. / cleared 2010-09-20

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)