Class 2 Device Recall StarMedTec LightTrail Reusable Fibers

• Date Initiated by Firm: September 30, 2014
• Date Posted: October 08, 2014
• Recall Status: Terminated on November 26, 2014
• Recall Number: Z-0049-2015
• Recall Event ID: 69404
• 510(K)Number: K111475
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453
• Code Information: Material/Part Number: 6453 Batch Code: 2011-00238
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: 508-382-9555
• Manufacturer Reason for Recall: Product is not cleared for use with lasers other than the Auriga XL system
• FDA Determined Cause: No Marketing Application
• Action: Boston Scientific sent an " Urgent Medical Device Recall Removal Immediate Action Required" letter dated September 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the account to check their inventory, remove any affected product from their inventory, and contact Boston Scientific for further instructions on returns. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. We ask that you complete and return the Reply Verification Tracking form, included with this letter, according to the instructions on page 3, even if you no longer have inventory of the recalled lots. If you identify any of the affected lots within your inventory, please segregate it immediately and you will be contacted by Boston Scientific with additional instructions after you return your form. You will receive credit, as appropriate, for any affected product in your inventory. Fax to : Field Action Center at 1-866-213-1806. For further questions call (508) 382-9555
• Quantity in Commerce: 5 units
• Distribution: US Distribution including the states of NY and TX.
• 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