BEUDAMED
    FDA Recall 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 · Initiated August 3, 2014

    Recall

    Recall Number
    Z-2642-2014
    Event Number
    68997
    Firm
    EMG Technology Co., Ltd.
    FEI Number
    3003803075
    Product Code
    JCX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 3, 2014
    Posted
    September 13, 2014
    Terminated
    August 25, 2015
    Address
    No. 58, 35 Road, Taichung Industrial Park Taichung 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.

    Action

    A recall letter, dated August 6, 2014, was sent via email which identified the product, problem, and actions to be taken.

    Distribution

    US Distribution in IL.

    Quantity

    1452