National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual
National Biological Corp is recalling Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-083 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/packaging error involving the wrong user manual.
Plain-English summary
National Biological Corp is recalling 124 units of the Dermalight 80 Model Number UVB-080 phototherapy light unit. The Dermalight 80 is used to provide ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
The recall is due to a packaging error where the incorrect manual may have been included with the product. Specifically, the UVB-080 devices may have been packaged with the manual intended for a UVA-083 device.
The affected units include batches 7839 and 7951, with serial numbers ranging from D80-12748 to D80-12871. These units were distributed worldwide, including nationwide in the United States and in Canada, Brazil, Malaysia, and Mexico. Consumers should check their devices for these specific batch and serial numbers and contact the manufacturer for instructions.
The recalled product
- Product
- Dermalight 80 Model Number UVB-080, 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
- 124
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 (1)
- Serial numbers D80-12748 to D80-12871.
Distribution
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