Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
FDA Recall Z-0760-2013 · Posted 2013-01-31
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Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeJAQ
Date Initiated2012-04-12
Date Terminated2014-04-10
Product Quantity152 units
Reason for Recall
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Firm Action
Varian Medical Systems an an Urgent Medical Device Correction letters dated April 11, 2012 and May 8, 2012 to all affected customers. The April notification advised of an anomaly with titanium rectal retractors, and the correction was expanded in May to include stainless steel retractors. In both notifications, users were instructed to discontinue use and quarantine their cleaned and sterilized devices for collection by Varian field service engineers. Users were requested to return an enclosed reply form to respond with number of units in inventory.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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