Recall Z-0759-2013— Varian Medical Systems, Inc.

Name: FDA recall Z-0759-2013
Creator: U.S. Food and Drug Administration
Published: 2012-04-12

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2012-04-12, terminated 2014-04-10. It names one FDA 510(k) clearance: K011657. Product: Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.. Reason: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-12
Terminated: 2014-04-10
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K011657 — HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTORMick Radio-Nuclear Instruments, Inc.·cleared 2001-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.