Recall Z-0050-2015— Boston Scientific Corporation

Name: FDA recall Z-0050-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-30

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2014-09-30, terminated 2014-11-26. It names one FDA 510(k) clearance: K111475. Product: StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455. Reason: Product is not cleared for use with lasers other than the Auriga XL system.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-09-30
Terminated: 2014-11-26
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111475 — AURIGA XLStarmedtec GmbH·cleared 2011-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.