BEUDAMED
    FDA Enforcement Class I Ongoing

    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

    Recall: Z-1065-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1065-2024
    Event ID
    93821
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    January 10, 2024
    Classification Date
    February 24, 2024
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420, United States

    Description

    AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004

    Reason

    Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

    Code Info

    UDI/DI Case: 50190752114102, Each: 10190752114104; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.

    Distribution

    Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa

    Quantity

    1,800,000 units