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U.S. Department of Health and Human Services

Class 2 Device Recall StarMedTec LightTrail Reusable Fibers

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  Class 2 Device Recall StarMedTec LightTrail Reusable Fibers see related information
Date Initiated by Firm September 30, 2014
Date Posted October 08, 2014
Recall Status1 Terminated 3 on November 26, 2014
Recall Number Z-0051-2015
Recall Event ID 69404
510(K)Number K111475  
Product Classification Powered laser surgical instrument - Product Code GEX
Product StarMedTec LightTrail¿ Reusable Fibers, 800 um; Material/Part Number: 6457
Code Information Material/Part Number: 6457  Batch Code: 2011-00217, 2012-00239, 2012-00249,   2012-00258
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 2		 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 33 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 and Original Applicant = STARMEDTEC GMBH
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