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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

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
Recall Number Z-0065-2014
Classification Class II
Code Info Lots #6078184-1, #6078184-2, #6078184-4
Product Distributed Qty 3 sets
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.

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 Letter
Distribution Pattern Worldwide distribution: US (nationwide) distribution in CA and in the country of India.
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