FDA Enforcement
Class II
Terminated
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Recall: Z-1614-2018
·
Reported June 13, 2018
Enforcement
- Recall Number
- Z-1614-2018
- Event ID
- 80020
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ii - Vi Incorporated
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 13, 2018
- Initiation Date
- December 13, 2017
- Classification Date
- June 2, 2018
- Termination Date
- April 22, 2020
- Address
- 375 Saxonburg Blvd, N/A, Saxonburg, PA, 16056-9430, United States
Description
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Reason
Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
Code Info
Model Numbers: 25-0655 & 25-0657
Distribution
US Distribution to Oregon.
Quantity
323,972