BEUDAMED
    FDA Recall Terminated

    Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.

    Recall: Z-1724-2009 · Initiated May 29, 2009

    Recall

    Recall Number
    Z-1724-2009
    Event Number
    52057
    Firm
    Amvex Corporation
    FEI Number
    3003272769
    Product Code
    CCN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 29, 2009
    Posted
    August 21, 2009
    Terminated
    August 19, 2011
    Address
    10-121 Granton Drive, Richmond Hill Canada

    Description

    Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment.

    Reason

    The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully.

    Action

    An "Urgent: Medical Device Recall" letter dated May 29, 2009 was issued to the affected direct accounts on the same date, informing them that the Integrated Flowmeters shipped between April 12, 2007 and August 31, 2007 may experience damage to the o-ring which helps to control the flow of gas from the flowmeter portion of the outlet. Units with a damaged o-ring might deliver higher amounts of gas and/or not be able to shut off fully. The letter provided a list of the affected serial numbers, and asked the accounts to confirm that they have flowmeters from the recall time period. The accounts were provided with interim instructions to use the flowmeters during the replacement period, and were instructed to call an Amvex Corporation Representative at 1-866-462-6839 with at least one of the affected serial numbers and provide the number of units that need replacement. The Amvex Corporation will send new flowmeters for replacement, with instructions on how to replace, record the serial numbers and return the recalled units. If the accounts distributed the units, they were requested to forward the recall letter to the end users. The accounts were also requested to complete the enclosed reply sheet acknowledging receipt of the letter and fax it back to the Amvex Corporation at 1-905-764-7743. Direct questions to the Amvex Corporation by calling 1-866-462-6839.

    Distribution

    Worldwide Distribution -- US (including Puerto Rico), Canada, Iran, Peru, Taiwan and Thailand.

    Quantity

    1,424 units