BEUDAMED
    FDA Enforcement Class II Terminated

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    Recall: Z-2642-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2642-2014
    Event ID
    68997
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EMG Technology Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2014
    Initiation Date
    August 3, 2014
    Classification Date
    September 12, 2014
    Termination Date
    August 25, 2015
    Address
    No. 58, 35 Road, Taichung Industrial Park, Taichung, N/A, N/A, Taiwan

    Description

    Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.

    Reason

    suction canister lids may have occluded ports.

    Code Info

    Product Model No: SUAOI Serial Number ranges: SUI4B01391-SU14B02117. SU14C00556-SU14C01280

    Distribution

    US Distribution in IL.

    Quantity

    1452