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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 61879
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 2012-04-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. All lots Class II A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. 152 units Z-0760-2013
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. All lots Class II A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions. 344 pieces Z-0759-2013
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