BEUDAMED
    FDA Recall Terminated

    United Nuclear Scientific High Power Handheld Lasers. Laser products

    Recall: Z-0051-2018 · Initiated August 25, 2016

    Recall

    Recall Number
    Z-0051-2018
    Event Number
    78389
    Firm
    United Nuclear Scientific Supplies, LLC
    FEI Number
    3013936624
    Product Code
    REA
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    August 25, 2016
    Terminated
    October 27, 2020
    Address
    16429 Upton Rd, Suite # 1, East Lansing, MI, 48823-9327

    Description

    United Nuclear Scientific High Power Handheld Lasers. Laser products

    Reason

    Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.

    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]

    Distribution

    US Distribution

    Quantity

    3