PlainRecalls
FDA Devices Moderate Class II Terminated

Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Reported: February 6, 2013 Initiated: April 12, 2012 #Z-0759-2013

Product Description

Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Reason for Recall

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Details

Units Affected
344 pieces
Distribution
US Nationwide Distribution
Location
Charlottesville, VA

Frequently Asked Questions

What product was recalled?
Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.. Recalled by Varian Medical Systems, Inc.. Units affected: 344 pieces.
Why was this product recalled?
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 6, 2013. Severity: Moderate. Recall number: Z-0759-2013.