National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual
National Biological Corp is recalling six Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-080 device.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation error (incorrect manual) rather than a functional defect or contamination.
Plain-English summary
National Biological Corp is recalling six units of the Dermalight 80 Model Number UVB-083 phototherapy light unit. The device is used to provide ultraviolet radiation therapy for diagnosed skin disorders such as psoriasis and vitiligo.
The recall was initiated because the incorrect manual may have been packaged with the product. Specifically, the UVB-083 devices may have included the manual intended for a UVA-080 device. The affected units are identified by Batch 007778 and Serial numbers D83-30016 to D83-30021.
The recalled units were distributed in the United States, including the states of Alabama, California, Minnesota, and North Carolina. Consumers who possess these specific units should stop using them and contact National Biological Corp for instructions on how to obtain the correct manual or a replacement.
The recalled product
- Product
- Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
- Manufacturer
- National Biological Corp
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- The following batch and serial numbers are affected by the recall: Batch 007778
- Serial numbers D83-30016 to D83-30021.
Distribution
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