BEUDAMED
    FDA Recall Terminated

    BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

    Recall: Z-2332-2010 · Initiated June 22, 2010

    Recall

    Recall Number
    Z-2332-2010
    Event Number
    56162
    Firm
    Westmed Inc
    FEI Number
    1000374126
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2010
    Posted
    September 8, 2010
    Terminated
    March 22, 2011
    Address
    5580 South Nogales Hwy, Ste 170, Tucson, AZ, 85706

    Description

    BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

    Reason

    This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.

    Action

    The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email [email protected] to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist. If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.

    Distribution

    Worldwide distribution.

    Quantity

    22145