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
- Company
- Cincinnati Sub-Zero Products Inc
- Recall Initiated
- June 1, 2011
- Posted
- July 27, 2011
- Terminated
- August 2, 2013
- Recall Number
- Z-2888-2011
- Quantity
- 5474 units
- Firm Location
- Cincinnati, OH
Reason for Recall
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.
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.