Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Recall
- Recall Number
- Z-0759-2013
- Event Number
- 61879
- Firm
- Varian Medical Systems, Inc.
- FEI Number
- 3000206172
- Product Code
- JAQ
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 12, 2012
- Posted
- January 31, 2013
- Terminated
- April 10, 2014
- Address
- 700 Harris St, Ste 109, Charlottesville, VA, 22903-4584
Description
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
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.
US Nationwide Distribution
344 pieces