FDA Enforcement
Class II
Terminated
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Recall: Z-0050-2015
·
Reported October 15, 2014
Enforcement
- Recall Number
- Z-0050-2015
- Event ID
- 69404
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 15, 2014
- Initiation Date
- September 30, 2014
- Classification Date
- October 8, 2014
- Termination Date
- November 26, 2014
- Address
- 100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States
Description
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
Code Info
Material/Part Number: 6455 Batch Code: 2012-00268, 2013-00443
Distribution
US Distribution including the states of NY and TX.
Quantity
7 units