Recall Z-1778-2013
National Biological Corp · initiated April 9, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
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.
FDA-determined cause: Labeling mix-ups
Action taken
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: infor@PhototherapyExperts.com.
Details
- Recall number
- Z-1778-2013
- Initiated
- April 9, 2013
- Posted by FDA
- July 19, 2013
- Terminated
- February 24, 2014
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Quantity
- 124 units
- Distribution
- 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.
- Recalling firm
- National Biological Corp, Beachwood, OH