Reported Oct 30, 2013 · Terminated
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 700 Harris St Ste 109 · Charlottesville, VA · 22903-4584
Is this the product you have?
- 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
- Lot codes and dates
Lots #6078184-1#6078184-2#6078184-4
- Amount recalled
- 3 sets
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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