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Varian Medical Systems, Inc. recalls VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Templat
Recalled October 30, 2013 · FDA recall Z-0065-2014 · Varian Medical Systems
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. · FDA Class II
Units
3 sets
Sold at
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Description
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.
Product
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
Manufacturer(s)
Varian Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →