Recalls / —

—#130434

Product

StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453

FDA product code

GEX — Powered Laser Surgical Instrument

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K111475

Affected lot / code info

Material/Part Number: 6453  Batch Code: 2011-00238

Why it was recalled

Product is not cleared for use with lasers other than the Auriga XL system

Root cause (FDA determination)

No Marketing Application

Action the firm took

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

Recalling firm

Firm

Boston Scientific Corporation

Address

100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern

US Distribution including the states of NY and TX.

Timeline

Recall initiated

2014-09-30

Posted by FDA

2014-10-08

Terminated

2014-11-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #130434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.