Z-0065-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2013
- Initiation Date
- August 9, 2013
- Termination Date
- April 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 sets
Product Description
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.
Distribution Pattern
Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
Code Information
Lots #6078184-1, #6078184-2, #6078184-4