Events

Recall of Device Recall High Power Handheld Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by United Nuclear Scientific Supplies, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78389
  • Event Risk Class
    Class 2
  • Event Number
    Z-0051-2018
  • Event Initiated Date
    2016-08-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159398
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laser pointer - Product Code REA
  • 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 : sales@unitednuclear.com

Device

Device Recall High Power Handheld Laser
  • Model / Serial
    Surveying Leveling and Alignment (SLA) laser products
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution
  • Product Description
    United Nuclear Scientific High Power Handheld Lasers. || Laser products
  • Manufacturer
    United Nuclear Scientific Supplies, LLC

Manufacturer

United Nuclear Scientific Supplies, LLC
  • Manufacturer Address
    United Nuclear Scientific Supplies, LLC, 16429 Upton Rd, Suite #1, East Lansing MI 48823-9327
  • Source
    USFDA