Device recall
Z-2058-2012: Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in…
FDA device recall · Class II · Westone Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-2058-2012 |
|---|---|
| Recall event | 62520 |
| 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. |
| Product code | KMJ |
| Recalling firm | Westone Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2012 |
| FEI number | 2094377 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database