Z-0760-2013Class II

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator...

Name: Z-0760-2013 Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator...
Creator: Varian Medical Systems, Inc.
Published: 2012-04-12
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-04-12 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. began a recall of Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy on 2012-04-12. FDA classified it as Class II and gives the reason as "A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0760-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-12
Posted: 2013-01-31
Terminated: 2014-04-10
Recalling firm: Varian Medical Systems, Inc.
Product: Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 152 units
Distribution: US Nationwide Distribution
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0760-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0759-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-31
Z-0760-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-31

Product code JAQ

K011657Class IIHdr Tandem/ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. / cleared 2001-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)