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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
White Acetal Titanium Rectal Retractor		see related information
Date Posted January 31, 2013
Recall Number Z-0760-2013
Product Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Code Information All lots
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville, Virginia 22903-4584
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Pete Coronado
434-977-8495
Reason for
Recall		 A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
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.
Quantity in Commerce 152 units
Distribution US Nationwide Distribution
 
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