Blanketrol III — Class II medical device recall Z-2209-2013
Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2013-09-25, distributed in AK, AR, AZ, CA, CO, DC, DE, FL…. During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Techn
| Recall number | Z-2209-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2013-09-03 |
| Classified | 2013-09-16 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-08-22 |
| Distributed | 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 |
| Countries outside the US | AR, AU, BE, CA, CL, CN, CR, DE, ES, GB, HK, HN, HR, ID, IL, IN, KR, KW, MX, NL, NZ, PE, PH, SA, SG, TH |
| Reason classes | labeling |
| Serial numbers | 112-3-01949, 112-3-02021, 112-3-02102, 114-3-02171 |
| Model numbers | 233, 86107/06107/6107, 86207/6207 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2209-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.