Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0051-2018Class II

United Nuclear Scientific High Power Handheld Lasers. Laser products

United Nuclear Scientific Supplies, LLC / initiated 2016-08-25 / Terminated

United Nuclear Scientific Supplies, LLC began a recall of United Nuclear Scientific High Power Handheld Lasers. Laser products on . FDA classified it as Class II and gives the reason as "Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0051-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
United Nuclear Scientific Supplies, LLC
Product
United Nuclear Scientific High Power Handheld Lasers. Laser products
Product code
REA High-Power Laser Light Show Projector
Reason for recall
Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.
FDA root cause
Radiation Control for Health and Safety Act
Action
United Nuclear will bring defect into compliance by : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving three units will consist of the following: 1. Notification will be given to purchasers per 21 CFR 1003.21. 2 .A full refund will be offered to all purchasers upon return of their laser pointers. 3. Postage paid shipping containers will be provided to all purchasers for the return of the laser pointers. Please note that United Nuclear Scientific Supplies, LLC is responsible for the correction of all noncompliant products If you have any questions, please call (517) 339-3587, or email : [email protected]
Quantity in commerce
3
Distribution
US Distribution
Product codes and lots
Surveying Leveling and Alignment (SLA) laser products

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0051-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0051-2018Class IITerminatedFDA Mandated