Class 2 Device Recall MicroAir Vibrating Mesh Nebulizer Medication Bottle

• Date Initiated by Firm: November 02, 2004
• Date Posted: January 05, 2005
• Recall Status: Terminated on June 26, 2007
• Recall Number: Z-0382-05
• Recall Event ID: 30363
• 510(K)Number: K923024
• Product Classification: Nebulizer (Direct Patient Interface) - Product Code CAF
• Product: 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
• Code Information: Bottle lots 43A, 53A, 63A, 73A, 83A, 93A, X3A, Y3A and Z3A, a component of Nebulizer model NE-U22 serial numbers 3400001A and higher, 3500001A and higher, 3600001A and higher, 3700001A and higher, 3800001A and higher, 3900001A and higher, 3X00001A and higher, 3Y00001A and higher, and 3Z00001A through 3Z00696A. Medication bottles with either a blue dot or a blue O-ring were manufactured after corrections were made and are not subject to the recall.
• FEI Number: 1450057
• Recalling Firm/ Manufacturer: Omron Healthcare, Inc.; 1200 Lakeside Drive; Bannockburn IL 60015-1243
• For Additional Information Contact: Ms. Helen A. Reetz; 847-680-6200
• Manufacturer Reason for Recall: A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 63,560 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = CAF