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
FDA Recall Z-2888-2011 · Posted 2011-07-27
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Recalling FirmCincinnati Sub-Zero Products Inc
Recall StatusTerminated
Product CodeDWJ
Date Initiated2011-06-01
Date Terminated2013-08-02
Product Quantity5474 units
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.
Firm 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 [email protected] or call (800) 989-7373 or (513) 772-8810.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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