FDA Device recall Z-0065-2014
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 *…
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 *… by Varian Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0065-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-09 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Lots #6078184-1, #6078184-2, #6078184-4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0065-2014%22
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