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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0051-2018 | Class II | Terminated | FDA Mandated |
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