Class 2 Device Recall Laser Surgical Fiber

• Date Initiated by Firm: December 18, 2007
• Date Posted: April 09, 2008
• Recall Status: Terminated on April 09, 2008
• Recall Number: Z-0585-2008
• Recall Event ID: 46251
• 510(K)Number: K011703
• Product Classification: Surgical Powered Laser Instrument - Product Code GEX
• Product: Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
• Code Information: Lot number 61280807.
• FEI Number: 1720381
• Recalling Firm/ Manufacturer: Lumenis, Inc.; 3959 W 1820 S; Salt Lake City UT 84104-4951
• For Additional Information Contact: 801-656-2300
• Manufacturer Reason for Recall: Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355.
• Quantity in Commerce: 59 units.
• Distribution: MA
• 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 = GEX