BEUDAMED
    FDA Enforcement Class I Terminated

    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.

    Recall: Z-1948-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1948-2014
    Event ID
    68242
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ventlab LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 16, 2014
    Classification Date
    July 3, 2014
    Termination Date
    November 17, 2015
    Address
    2710 Northridge Dr Nw, Suite A, Grand Rapids, MI, 49544-9112, United States

    Description

    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.

    Reason

    The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

    Code Info

    Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.

    Distribution

    US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,

    Quantity

    251,384