Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-P
FDA device recall Z-0715-2007 · posted 2007-04-04 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
- Action taken
- The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYL
- Quantity affected
- 1.5 million units
- Distribution
- Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.
- Date initiated
- 2007-03-05
- Date posted
- 2007-04-04
- Date terminated
- 2008-01-09
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802) | Bausch & Lomb, Incorporated | 2002-05-31 |