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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65488
Product Type Devices
Status Ongoing
Recalling Firm National Biological Corp
City Beachwood
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-09
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871. Class III The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. 124 units Z-1778-2013