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

FDA device recall Z-0050-2015 · posted 2014-10-08 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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

Root cause

No Marketing Application

Status

Terminated

Product code

GEX

Quantity affected

7 units

Distribution

US Distribution including the states of NY and TX.

Date initiated

2014-09-30

Date posted

2014-10-08

Date terminated

2014-11-26

Location

Marlborough, MA

Related 510(k) clearances