Cincinnati Sub-Zero Blanketrol III Manuals Recalled for Labeling Error
Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (verbiage added back to manuals) without reporting any injuries, illnesses, or specific functional defects. This aligns with the rubric for moderate severity involving labeling errors.
Plain-English summary
Cincinnati Sub-Zero Products Inc. is recalling the Blanketrol III Operations (57201-N) and Operations & Technical (56201-Q) manuals. The recall involves 396 units of the 115V model and 385 units of the 230V model, which were distributed worldwide, including in the United States and numerous international locations.
During a label review, the company discovered that specific verbiage was added back into the manuals during Engineering Change Notice M111-4260, released on December 29, 2011. This text had previously been removed to clarify the intended use of the device and to align with subsequent 501(K) approval. The presence of this text in the manuals represents a labeling error.
The affected devices are Hyper-Hypothermia devices used to lower or raise a patient's temperature. Users should check their manual version and serial numbers against the recall list provided by the manufacturer. The FDA has classified this as a Class II recall.
The recalled product
- 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.
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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