Reported Sep 25, 2013 · Terminated
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241…
Cincinnati Sub-Zero Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cincinnati Sub-Zero Products Inc · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- 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.
- Lot codes and dates
- Part number
86107/06107/6107 (115V)Serial #s: 112-3-02021112-3-02102 through 124-3-02783074-3-00388081-3-00489081-3-00493082-3-00511091-3-00935094-3-01261094-3-01265094-3-01272094-3-01304094-3-01308101-3-01384093-3-01045093-3-01046093-3-01069084-3-00775073-3-00315091-3-00918091-3-00919073-3-00279094-3-01262071-3-00183092-3-00983094-3-01255064-3-00114072-3-00219072-3-00222072-3-00230072-3-00258081-3-00499081-3-00500064-3-00116064-3-00117092-3-01021073-3-00305073-3-00314082-3-22572082-3-22573101-3-01380073-3-00317074-3-00341091-3-00932094-3-01310101-3-01374082-3-00559092-3-00983094-3-01255094-3-01305062-3-00029093-3-01048094-3-01240102-3-01504 & 094-3-01243
- Part number
81 of 81 codes
86207/6207 (230V) Serial #s: 112-3-01949114-3-02171 through 124-3-02764072-3-00247073-3-00266073-3-00282082-3-00564071-3-00132071-3-00152073-3-00309082-3-00533082-3-00534082-3-00565082-3-00568084-3-00768084-3-00770084-3-00777084-3-00778084-3-00779084-3-00780084-3-00781084-3-00787084-3-00788091-3-00836091-3-00877091-3-00878091-3-00902092-3-01007092-3-01008092-3-01011102-3-01423102-3-01426103-3-01592103-3-01593103-3-01594103-3-01595103-3-01601093-3-01072093-3-01073093-3-01076093-3-01078093-3-01084093-3-01085093-3-01086093-3-01087093-3-01088093-3-01104093-3-01105093-3-01106093-3-01107093-3-01108103-3-01573103-3-01574103-3-01575071-3-00178071-3-00180074-3-00393074-3-00394074-3-00395074-3-00396074-3-00404
- Part number
- Amount recalled
- 115V - 396 units; 230V - 385 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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