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
  • 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
  • 1 Event

Fabricant

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