BEUDAMED
    FDA Enforcement Class I Terminated

    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

    Recall: Z-0177-2013 · Reported November 7, 2012

    Enforcement

    Recall Number
    Z-0177-2013
    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

    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.

    Reason

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

    Code Info

    Product Code: VN4100OB, Lot #102015.

    Distribution

    Nationwide Distribution including IL, OH, NY and TN.

    Quantity

    14,602 total for all units