BEUDAMED
    FDA Enforcement Class I Terminated

    Seattle PAP Plus, MP02260

    Recall: Z-1439-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1439-2023
    Event ID
    92049
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2023
    Initiation Date
    April 17, 2023
    Classification Date
    May 17, 2023
    Termination Date
    September 3, 2024
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Seattle PAP Plus, MP02260

    Reason

    Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

    Code Info

    UDI-DI: 04048675548904; All lots distributed prior to 03/20/2023 (lots other than 0367.2702.13).

    Distribution

    Domestic: US Nationwide Distribution.

    Quantity

    32,050 untis