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Recall Observatory FDA recall evidence

Device product

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.

Z-2058-2012

July 13, 2012

Class II

Product summary

Firm
Westone Laboratories, Inc.
Event
Event 62520
Status
Terminated
Classification
Class II
Quantity
Approx 100k sold annually x 15 years.
Official record key
device-enforcement:Z-2058-2012

Official wording

Reason: Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination