BEUDAMED
    FDA Enforcement Class I Terminated

    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.

    Recall: Z-0345-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0345-2018
    Event ID
    78636
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    November 29, 2014
    Classification Date
    January 24, 2018
    Termination Date
    February 5, 2021
    Address
    75 N Fairway Dr, N/A, Vernon Hills, IL, 60061-1845, United States

    Description

    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.

    Reason

    Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.

    Code Info

    0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134347 0001134348 0001135401 0001135402 0001137252 0001137253 0001139266 0001139267 0001145147 0001145148 0001145149 0001156843

    Distribution

    US Nationwide Distribution

    Quantity

    16,670 units in total