Class 2 Device Recall

• Date Initiated by Firm: August 25, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on December 15, 2003
• Recall Number: Z-1279-03
• Recall Event ID: 27058
• 510(K)Number: k954340
• Product Classification: Unit, Phacofragmentation - Product Code HQC
• Product: Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
• Code Information: Julian date coded ''2003163''
• Recalling Firm/ Manufacturer: Bausch & Lomb Incorporated; 1501 Graves Mill Road; Lynchburg VA 24502
• For Additional Information Contact: Jennifer B. Murray; 585-338-8460
• Manufacturer Reason for Recall: The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
• FDA Determined 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 in Commerce: 22 boxes
• Distribution: Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HQC and Original Applicant = STORZ