Devices

Device Recall WarmAir Model 135 Convective Warming Device

Model / Serial
100V - Part Number: 86185; 115V - Part Number: 86186; and 230V - Part Number 86187. Serial Numbers: 032-1351178 thru 104-1356908 and 104-1356910 to 104-1356915.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.
Product Description
WarmAir Model 135 Convective Warming Device, || Cincinnati Sub-Zero Products, Inc. || Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket
Manufacturer
Cincinnati Sub-Zero Products Inc
1 Event
- Recall of Device Recall WarmAir Model 135 Convective Warming Device

Manufacturer

Cincinnati Sub-Zero Products Inc

Manufacturer Address
Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241
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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