Recall Z-2052-2008 ยท NKX Needle, Phacoemulsification, Reprocessed
Bausch & Lomb Inc
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 60 Degree, REF MVS1601A, 6 needles per pouch, nonsterile.
| Date | Sep 16, 2008 (initiated Mar 26, 2008) |
| Status | Terminated |
| Reason | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 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, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041998 | PHACO CHOP NEEDLES Bausch & Lomb, Inc., Aug 16, 2004 |