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Recall Observatory FDA recall evidence

Device product

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

Z-0049-2015

September 30, 2014

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 69404
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-0049-2015

Official wording

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

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

Distribution pattern: US Distribution including the states of NY and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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