Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC; Distributed by:
FDA device recall Z-0382-05 · posted 2005-01-05 · Terminated
Recall details
- Recalling firm
- Omron Healthcare, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 63,560 units
- Distribution
- Nationwide
- Date initiated
- 2004-11-02
- Date posted
- 2005-01-05
- Date terminated
- 2007-06-26
- Location
- Bannockburn, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NE-U04/NE U04F (K923024) | Omron Healthcare, Inc. | 1992-09-15 |