Devices

Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System

Model / Serial
Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed to one customer in MI, and internationally (Taiwan)
Product Description
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Manufacturer
Cincinnati Sub-Zero Products Inc
1 Event
- Recall of Device Recall 115 V Blanketrol II, Model 222S HyperHypothermia System

Manufacturer

Cincinnati Sub-Zero Products Inc

Manufacturer Address
Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
Manufacturer Parent Company (2017)
Gentherm, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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