Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
FDA device recall Z-1554-2014 · posted 2014-05-06 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc- Greenville Solutions Plant
- Reason for recall
- Out of specification results for one of the two disinfectants.
- Action taken
- Consignees were notified via registered mail starting 04/21/2014.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LYL
- Quantity affected
- 256,440 bottles
- Distribution
- US Nationwide.
- Date initiated
- 2014-04-21
- Date posted
- 2014-05-06
- Date terminated
- 2015-01-09
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BPZ02 MULTIPURPOSE SOLUTION (K083757) | Bausch & Lomb, Inc. | 2009-11-18 |