FDAFDA · Food and drugs·Recall number Z-1778-2013
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.
Published July 31, 2013 · Recall initiated: April 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- National Biological Corp
- Distributor
- 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.
- Lot
- The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.