Events

Rappel de Device Recall OTO EASE

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 Westone Laboratories, 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
    62520
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2058-2012
  • Date de mise en oeuvre de l'événement
    2012-07-13
  • Date de publication de l'événement
    2012-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110825
  • 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
    Lubricant, patient - Product Code KMJ
  • Cause
    Westone is recalling all oto ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
  • Action
    Westone Laboratories sent an Urgent Recall letter and Press Release to distributors and customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine product subject to recall and discard or return the product to Westone. In addition, if the affected product have been further distributed please identify your customers and notify them at once of this product recall. Consumers with questions may contact Westone Laboratories at 1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email at otoeaserecall@westone.com.

Device

Device Recall OTO EASE
  • Modèle / numéro de série
    Individual products are not identified with lot numbers. There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial. No expiry is applied to the finished products.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom.
  • Description du dispositif
    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. || Product Usage: || The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
  • Manufacturer
    Westone Laboratories, Inc.

Manufacturer

Westone Laboratories, Inc.
  • Adresse du fabricant
    Westone Laboratories, Inc., 2235 Executive Cir, Colorado Springs CO 80906-4137
  • Société-mère du fabricant (2017)
    Westone Laboratories Inc.
  • Source
    USFDA