Z-1778-2013 Class III Terminated
FDA device recall Z-1778-2013 was initiated by National Biological Corp on April 9, 2013 and is designated Class III. Reason for recall: The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. The recall status is terminated (terminated February 24, 2014). Affected quantity: 124 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2013
- Initiation Date
- April 9, 2013
- Termination Date
- February 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124 units
Product Description
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.
Reason for Recall
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.
Code Information
The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.