Z-1779-2013 Class III Terminated
FDA device recall Z-1779-2013 was initiated by National Biological Corp on April 8, 2013 and is designated Class III. Reason for recall: The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. The recall status is terminated (terminated February 24, 2014). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- April 8, 2013
- Termination Date
- February 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product 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 for Recall
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Distribution Pattern
US distribution including the states of: AL, CA, MN, and NC.
Code Information
The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.