BEUDAMED
    FDA Enforcement Class I Terminated

    Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

    Recall: Z-0017-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0017-2013
    Event ID
    63174
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Accutron Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    April 29, 2012
    Classification Date
    October 9, 2012
    Termination Date
    February 1, 2013
    Address
    1733 W Parkside Ln, N/A, Phoenix, AZ, 85027-1382, United States

    Description

    Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit 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.

    Code Info

    Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142.

    Distribution

    US Nationwide Distribution

    Quantity

    220 units total