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
  • 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
  • 1 Event

Manufacturer

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