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

Recall Insight

This FDA Devices action (record #Z-0065-2014) was formally reported on October 30, 2013, with the manufacturer initiating the action on August 9, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Varian Medical Systems, Inc. is listed as the recalling firm, operating out of Charlottesville, VA. Federal records indicate 3 sets units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide distribution: US (nationwide) distribution in CA and in the country of India.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.