BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2888-2011 · Initiated June 1, 2011

    Recall

    Recall Number
    Z-2888-2011
    Event Number
    59023
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 1, 2011
    Posted
    July 27, 2011
    Terminated
    August 2, 2013
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241

    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

    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 [email protected] or call (800) 989-7373 or (513) 772-8810.

    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.

    Quantity

    5474 units