Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
This recall has been terminated (originally issued January 31, 2013).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- April 12, 2012
- Posted
- January 31, 2013
- Terminated
- April 10, 2014
- Recall Number
- Z-0760-2013
- Quantity
- 152 units
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Distribution
US Nationwide Distribution
Lot / Code Info
All lots
Root Cause
Component design/selection
Action Taken
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.