BEUDAMED
    FDA Enforcement Class I Terminated

    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    Recall: Z-0180-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0180-2013
    Event ID
    63347
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ventlab Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2012
    Initiation Date
    July 11, 2012
    Classification Date
    November 1, 2012
    Termination Date
    June 30, 2013
    Address
    155 Boyce Dr, N/A, Mocksville, NC, 27028-4187, United States

    Description

    AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    Reason

    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

    Code Info

    Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.

    Distribution

    Nationwide Distribution including IL, OH, NY and TN.

    Quantity

    14,602 total for all units