FDA Enforcement
Class III
Terminated
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.
Recall: Z-1779-2013
·
Reported July 31, 2013
Enforcement
- Recall Number
- Z-1779-2013
- Event ID
- 65494
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- National Biological Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 31, 2013
- Initiation Date
- April 8, 2013
- Classification Date
- July 19, 2013
- Termination Date
- February 24, 2014
- Address
- 23700 Mercantile Rd, N/A, Beachwood, OH, 44122-5900, United States
Description
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.
Reason
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Code Info
The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
Distribution
US distribution including the states of: AL, CA, MN, and NC.
Quantity
6 units