FDA Recall Terminated

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.

Recall: Z-1779-2013 · Initiated April 8, 2013

Recall

Recall Number
Z-1779-2013
Event Number
65494
Firm
National Biological Corp
FEI Number
1521608
Product Code
FTC
Status
Terminated
Root Cause
Labeling mix-ups
Initiated
April 8, 2013
Posted
July 19, 2013
Terminated
February 24, 2014
Address
23700 Mercantile Rd, Beachwood, OH, 44122-5900

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

The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.

Action

The firm, National Biological, sent an "VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated May 10, 2013 to its consignees/customers by UPS or other delivery service with a signature required. The letter described the product, problem and actions to be taken. Consignees/customers who do not respond to the letter will be contacted via telephone. The customers were instructed to check within your household to determine if you have any of the listed product; immediately destroy the incorrect User Manual, it is not necessary to return the product; record the Customer Name and or the Dermalight-80 serial number and complete and return the enclosed Verification Form, even if you do not have any User Manuals to destroy. Please contact your National Biological Corporation sales representative if you have any questions regarding this recall, any of our products, or would like assistance with the recall call 216-831-0600 or 800-338-5045 email: [email protected].

Distribution

US distribution including the states of: AL, CA, MN, and NC.

Quantity

6 units