FDA-Device2013-10-30Class II
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
Varian Medical Systems, Inc.
Hazard
The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
Sold states
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Affected count
3 sets
Manufactured in
700 Harris St Ste 109, N/A, Charlottesville, VA, United States
Products
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0065-2014Don't want to check this manually?
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