FDAClass IIOctober 15, 2014

StarMedTec LightTrail¿ Reusable Fibers recall

StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455

Why was StarMedTec LightTrail¿ Reusable Fibers recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Material/Part Number: 6455 Batch Code: 2012-00268, 2013-00443

Product
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Recalling firm
Boston Scientific Corporation
Quantity
7 units
Distribution
US Distribution including the states of NY and TX.
Recall date
October 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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