Recall Z-0065-2014
Varian Medical Systems, Inc. · initiated August 9, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lots #6078184-1, #6078184-2, #6078184-4
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.
Details
- Recall number
- Z-0065-2014
- Initiated
- August 9, 2013
- Posted by FDA
- October 24, 2013
- Terminated
- April 10, 2014
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 3 sets
- Distribution
- Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
- Recalling firm
- Varian Medical Systems, Inc., Charlottesville, VA