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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 65494
Product Type Devices
Status Ongoing
Recalling Firm National Biological Corp
City Beachwood
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern US distribution including the states of: AL, CA, MN, and NC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021. Class III The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device. 6 units Z-1779-2013