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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 66121
Product Type Devices
Status Ongoing
Recalling Firm Varian Medical Systems, Inc.
City Charlottesville
State VA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: US (nationwide) distribution in CA and in the country of India.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lots #6078184-1, #6078184-2, #6078184-4 Class II 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. 3 sets Z-0065-2014