Events

Retiro De Equipo (Recall) de Device Recall OTO EASE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Westone Laboratories, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    62520
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2058-2012
  • Fecha de inicio del evento
    2012-07-13
  • Fecha de publicación del evento
    2012-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110825
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lubricant, patient - Product Code KMJ
  • Causa
    Westone is recalling all oto ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
  • Acción
    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
  • Modelo / Serial
    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.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Westone Laboratories, Inc., 2235 Executive Cir, Colorado Springs CO 80906-4137
  • Empresa matriz del fabricante (2017)
    Westone Laboratories Inc.
  • Source
    USFDA