BEUDAMED
    FDA Enforcement Class I Terminated

    In-Line ventilator adaptor

    Recall: Z-1139-2022 · Reported June 8, 2022

    Enforcement

    Recall Number
    Z-1139-2022
    Event ID
    90061
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2022
    Initiation Date
    April 26, 2022
    Classification Date
    May 30, 2022
    Termination Date
    August 20, 2024
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    In-Line ventilator adaptor

    Reason

    There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

    Code Info

    M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.

    Distribution

    US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.

    Quantity

    9 units