Reported Aug 1, 2012 · Terminated
Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent…
Westone Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Westone Laboratories, Inc. · 2235 Executive Cir · Colorado Springs, CO · 80906-4137
Is this the product you have?
- Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles
- Product UsageThe product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids
- Lot codes and dates
- 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.
- Amount recalled
- Approx 100k sold annually x 15 years.
Where it was sold
- Nationwide
Why it was recalled
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
This product could cause temporary or reversible health problems — stop using it.
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