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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66155

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 03, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cincinnati Sub-Zero Products Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2209-2013
Recall number
Z-2209-2013
Initiated
September 03, 2013
Classification
Class II
Status
Terminated
Quantity
115V - 396 units; 230V - 385 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

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.

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.