Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The produ
FDA device recall Z-0553-2010 · posted 2009-12-22 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors.
- Action taken
- Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRC
- Quantity affected
- 159,672 bottles
- Distribution
- U.S. Nationwide, Canada and Hong Kong
- Date initiated
- 2009-10-30
- Date posted
- 2009-12-22
- Date terminated
- 2012-08-29
- 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 |
|---|---|---|
| RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K983836) | Polymer Technology Div. Wilmington Partners, L.P. | 1999-02-11 |