BEUDAMED
    FDA Recall Terminated

    HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

    Recall: Z-0935-2007 · Initiated April 26, 2007

    Recall

    Recall Number
    Z-0935-2007
    Event Number
    37863
    Firm
    Porous Media Corporation
    FEI Number
    1000221012
    Product Code
    BTT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2007
    Posted
    June 20, 2007
    Terminated
    December 10, 2011
    Address
    1350 Hammond Rd, Saint Paul, MN, 55110-5865

    Description

    HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

    Reason

    The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient)

    Action

    Customers were notified via a letter dated April 26, 2007. The letter describes the problem and product. Included with the letter, is a correction kit and installation instructions. The letter also urges the consignee to take an action to fill the attached form to confirm that the new intake filter restaint has been installed.

    Distribution

    WORLDWIDE DISTRIBUTION: USA including states of GA, MO, FL, UT, CO, TX, MT, MN, PA, OH, AL, SC, VA, KY, IA, MA, TN, IL, NM, UT, NJ, IN, and WI, and countries of CANADA, MEXICO, and JAPAN.

    Quantity

    178