FDAFDA · Food and drugs·Recall number Z-0065-2014
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
Published October 30, 2013 · Recall initiated: August 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc.
- Distributor
- Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
- Lot
- Lots #6078184-1, #6078184-2, #6078184-4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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