VARISOURCE Breast Template System for high-dose rate Brachytherapy — Class II medical device recall Z-0065-2014
Terminated recall by Varian Medical Systems, Inc., reported 2013-10-30, distributed nationwide. The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template S
| Recall number | Z-0065-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Charlottesville, VA, United States |
| Recall initiated | 2013-08-09 |
| Classified | 2013-10-24 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 3 sets |
| Lot numbers | 6078184-1, 6078184-2, 6078184-4 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0065-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.