BEUDAMED
    FDA Recall Terminated

    Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061

    Recall: Z-0382-05 · Initiated November 2, 2004

    Recall

    Recall Number
    Z-0382-05
    Event Number
    30363
    Firm
    Omron Healthcare, Inc.
    FEI Number
    1450057
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2004
    Posted
    January 5, 2005
    Terminated
    June 26, 2007
    Address
    1200 Lakeside Drive, Bannockburn, IL, 60015-1243

    Description

    Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by: Omron Healthcare, Inc., 300 Lakeview Parkway, Vernon Hills, IL 60061

    Reason

    A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.

    Action

    Omron sent 'Removal Notices' dated 11/2/04 to all of their direct accounts receiving the nebulizers during the affected time frame. The accounts were informed of the potential failure of the vibrating mechanism, and listed the serial numbers of the nebulizers that may contain the affected medication bottles. Medication bottles with either a blue dot near the bottle lever or a blue O-ring around the body of the bottle were manufactured after corrections were made and are not subject to the recall. Affected product should be returned to Omron for replacement. Any questions were directed to Customer Service at 800-231-4030.

    Distribution

    Nationwide

    Quantity

    63,560 units