BEUDAMED
    FDA Enforcement Class I Ongoing

    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    Recall: Z-3207-2024 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-3207-2024
    Event ID
    95239
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Percussionaire Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2024
    Initiation Date
    August 21, 2024
    Classification Date
    September 27, 2024
    Address
    130 Mcghee Rd Ste 109, N/A, Sandpoint, ID, 83864-8409, United States

    Description

    Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

    Reason

    Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

    Code Info

    No UDI/ Lots: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688

    Distribution

    US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey

    Quantity

    50,460 units