BEUDAMED
    FDA Enforcement Class II Terminated

    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

    Recall: Z-2319-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2319-2013
    Event ID
    66347
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DeVilbiss Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    March 7, 2013
    Classification Date
    September 30, 2013
    Termination Date
    November 6, 2014
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125, United States

    Description

    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

    Reason

    End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.

    Code Info

    Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25

    Distribution

    Worldwide Distribution - USA and the countries of Mexico and Canada.

    Quantity

    112,849