FDA Recall
Terminated
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.
Recall: Z-1280-03
·
Initiated August 25, 2003
Recall
- Recall Number
- Z-1280-03
- Event Number
- 27058
- Firm
- Bausch & Lomb Incorporated
- FEI Number
- 1000305478
- Product Code
- HQC
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 25, 2003
- Posted
- October 15, 2003
- Terminated
- December 15, 2003
- Address
- 1501 Graves Mill Road, Lynchburg, VA, 24502
Description
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.
Reason
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
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.
Distribution
Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
Quantity
44 boxes