Recall Z-1280-03 ยท HQC Unit, Phacofragmentation
Bausch & Lomb Incorporated
Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
| Date | Oct 15, 2003 (initiated Aug 25, 2003) |
| Status | Terminated |
| Reason | The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa. |
| Root cause | Other |
| Action | Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form. |
| Quantity | 44 boxes |
| Distribution | Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952259 | STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES Storz Instrument Co., Jun 14, 1995 |