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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

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

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