Recall Z-2058-2012— Westone Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Westone Laboratories, Inc., initiated 2012-07-13, terminated 2012-12-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product..
- Recalling firm
- Westone Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-13
- Terminated
- 2012-12-14
- Firm location
- Colorado Springs, CO, United States
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.
Reason for recall
Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.