Events

Rappel de Device Recall MicroAir Vibrating Mesh Nebulizer Medication Bottle

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Omron Healthcare, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    30363
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0382-05
  • Date de mise en oeuvre de l'événement
    2004-11-02
  • Date de publication de l'événement
    2005-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35735
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Nebulizer (Direct Patient Interface) - Product Code CAF
  • Cause
    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.

Device

Device Recall MicroAir Vibrating Mesh Nebulizer Medication Bottle
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    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
    Omron Healthcare, Inc.

Manufacturer

Omron Healthcare, Inc.
  • Adresse du fabricant
    Omron Healthcare, Inc., 1200 Lakeside Drive, Bannockburn IL 60015-1243
  • Source
    USFDA