FDA Device recall Z-2209-2013
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device u…
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device u… by Cincinnati Sub Zero Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-03 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cincinnati Sub Zero Products |
| Distribution | 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 |
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.
Reason
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.
Identifiers
| code_info | Part number: 86107/06107/6107 (115V), Serial #s: 112-3-02021, 112-3-02102 through 124-3-02783, 074-3-00388, 081-3-0048…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2013%22
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