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U.S. Department of Health and Human Services

Class 2 Device Recall High Power Handheld Laser

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 Class 2 Device Recall High Power Handheld Lasersee related information
Date Initiated by FirmAugust 25, 2016
Create DateDecember 08, 2017
Recall Status1 Terminated 3 on October 27, 2020
Recall NumberZ-0051-2018
Recall Event ID 78389
Product Classification Laser pointer - Product Code REA
ProductUnited Nuclear Scientific High Power Handheld Lasers. Laser products
Code Information Surveying Leveling and Alignment (SLA) laser products
Recalling Firm/
Manufacturer		 United Nuclear Scientific Supplies, LLC
16429 Upton Rd
Suite #1
East Lansing MI 48823-9327
For Additional Information Contact
517-339-3587
Manufacturer Reason
for Recall		Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionUnited 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
Quantity in Commerce3
DistributionUS Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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