BEUDAMED
    FDA Enforcement Class I Terminated

    AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    Recall: Z-1564-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1564-2018
    Event ID
    78412
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    April 27, 2017
    Classification Date
    May 10, 2018
    Termination Date
    May 9, 2019
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    Reason

    The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

    Code Info

    Part Number: 2K8019. Lots: 0001006159, 0001010401, 0001034518, 0001034519, 0001040641, 0001040642

    Distribution

    Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.

    Quantity

    2,262 units