BEUDAMED
    FDA Recall Terminated

    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

    Recall: Z-0020-2013 · Initiated April 29, 2012

    Recall

    Recall Number
    Z-0020-2013
    Event Number
    63174
    Firm
    Accutron Inc
    FEI Number
    2020813
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 29, 2012
    Posted
    October 9, 2012
    Terminated
    February 1, 2013
    Address
    1733 W Parkside Ln, Phoenix, AZ, 85027-1382

    Description

    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

    Reason

    Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.

    Action

    Accutron sent an Urgent Advisory Notice letter dated April 6, 2012 to all their customers who purchased the Ultra PC% Cabinet Mount Flowmeter. The letter informed the customers of the problem identified and actions to be taken. Customers were instructed to discontinue use or to continue use of the device only with extreme care until a replacement can be installed. Extreme care includes the use of the titration method for nitrous oxide administration coupled with close monitoring of both the patient and the actual gas flow through the flowtubes. For question contact Accutron at (800) 531-2221 or by email at [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    220 units total