Device Recall MicroAir Vibrating Mesh Nebulizer Medication Bottle

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Omron Healthcare, Inc., 1200 Lakeside Drive, Bannockburn IL 60015-1243
  • Source
    USFDA