Recall Z-0759-2013
Varian Medical Systems, Inc. · initiated April 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Codes / lots: All lots
Reason for recall
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
FDA-determined 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.
Details
- Recall number
- Z-0759-2013
- Initiated
- April 12, 2012
- Posted by FDA
- January 31, 2013
- Terminated
- April 10, 2014
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 344 pieces
- Distribution
- US Nationwide Distribution
- Recalling firm
- Varian Medical Systems, Inc., Charlottesville, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0760-2013 Class II | Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and…A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or… | 04/12/2012Terminated |