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.
This recall has been terminated (originally issued October 15, 2003).
- Company
- Bausch & Lomb Incorporated
- Recall Initiated
- August 25, 2003
- Posted
- October 15, 2003
- Terminated
- December 15, 2003
- Recall Number
- Z-1280-03
- Quantity
- 44 boxes
- Firm Location
- Lynchburg, VA
- Official Source
- View on FDA website ↗
Reason for Recall
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Distribution
Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
Lot / Code Info
Julian date coded ''2003163''
Root Cause
Other
Action Taken
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.