BEUDAMED
    FDA Recall Completed

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    Recall: Z-0489-2024 · Initiated October 27, 2023

    Recall

    Recall Number
    Z-0489-2024
    Event Number
    93332
    Firm
    Vyaire Medical
    FEI Number
    3013421741
    Product Code
    LSZ
    Status
    Completed
    Root Cause
    Process control
    Initiated
    October 27, 2023
    Posted
    December 5, 2023
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420

    Description

    vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)

    Reason

    Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

    Action

    Vyaire issued a Customer Notification to its consignees on 10/27/2023 via email. The notice explained the issue and how to identify the affected products. The firm is seeking the return of the circuits.

    Distribution

    US: Florida

    Quantity

    16 circuits