Events

Recall of Device Recall WarmAir Model 135 Convective Warming Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cincinnati Sub-Zero Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59023
  • Event Risk Class
    Class 2
  • Event Number
    Z-2888-2011
  • Event Initiated Date
    2011-06-01
  • Event Date Posted
    2011-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100848
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Thermal Regulating System - Product Code DWJ
  • Reason
    Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
  • Action
    Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 12, 2011 to all affected customers. The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a "Recall Response Form". For additional information e-mail WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810.

Device

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

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