Events

Recall of Device Recall OTO EASE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Westone Laboratories, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62520
  • Event Risk Class
    Class 2
  • Event Number
    Z-2058-2012
  • Event Initiated Date
    2012-07-13
  • Event Date Posted
    2012-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110825
  • Notes / Alerts
    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.
  • Extra notes in the data
    Lubricant, patient - Product Code KMJ
  • Reason
    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
  • Model / 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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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.
  • Manufacturer Address
    Westone Laboratories, Inc., 2235 Executive Cir, Colorado Springs CO 80906-4137
  • Manufacturer Parent Company (2017)
    Westone Laboratories Inc.
  • Source
    USFDA