Recall Z-0382-05 ยท CAF Nebulizer (Direct Patient Interface)
Omron Healthcare, Inc.
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
| Date | Jan 5, 2005 (initiated Nov 2, 2004) |
| Status | Terminated |
| Reason | A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization. |
| Root 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 C |
| Quantity | 63,560 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923024 | NE-U04/NE U04F Omron Healthcare, Inc., Sep 15, 1992 |