Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorpor
FDA device recall Z-3088-2011 · posted 2011-08-30 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
- Action taken
- Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 229/6-unit cases
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-07-27
- Date posted
- 2011-08-30
- Date terminated
- 2013-06-21
- 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 |
|---|---|---|
| BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM (K082473) | Bausch & Lomb, Inc. | 2009-01-05 |