Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip Angled 30 Degree, REF DP8430A, 6 needles per pouch,
FDA device recall Z-2049-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Action taken
- The recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned. If you have questions, contact Customer Service at 1-800-338-2020.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- NKX
- Quantity affected
- Total of all sizes - 4,055/6-needle packages
- Distribution
- Distribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, E
- Date initiated
- 2008-03-26
- Date posted
- 2008-09-16
- Date terminated
- 2010-01-21
- 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 |
|---|---|---|
| PHACO CHOP NEEDLES (K041998) | Bausch & Lomb, Inc. | 2004-08-16 |