FDAClass IIFebruary 6, 2013

Rectal Retractors recall: Contamination

Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Why was Rectal Retractors recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Recalling firm
Varian Medical Systems, Inc.
Quantity
152 units
Distribution
US Nationwide Distribution
Recall date
February 6, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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