BEUDAMED
    FDA Recall 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 · Initiated May 16, 2014

    Recall

    Recall Number
    Z-1948-2014
    Event Number
    68242
    Firm
    Ventlab LLC
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 16, 2014
    Posted
    July 3, 2014
    Terminated
    November 17, 2015
    Address
    2710 Northridge Dr Nw, Suite A, Grand Rapids, MI, 49544-9112

    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.

    Action

    The firm, Ventlab, issued a press dated May 14, 2014, stating Ventlab, LLC has initiated a voluntary medical device removal of a limited number of Ventlab" Resuscitator Bags. The bag series and lot numbers were included in a table as well as manufacture dates. In addition, Ventlab, LLC sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 19, 2014 to its distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to review and examine their inventory for affected product; stop using them and immediately contact Ventlab, LLC for further instructions on the return of these products; and if product was further distributed, identify their customers/consignees and notify them of this product removal. The customers were also instructed to complete and return the attached Return Response Form via fax at 1-800-400-8820, Attn: Quality Department, or email to: [email protected] as soon as possible and inform all affected personnel of this removal. Ventlab will send new corrected replacement resuscitation bags to customers once you return the affected product. If you have any questions regarding this action, please call Ventlab at 1-800-237-5481 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday, or 1-844-635-5326 or via e-mail at [email protected].

    Distribution

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

    Quantity

    251,384