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U.S. Department of Health and Human Services

Class 2 Device Recall White Acetal Titanium Rectal Retractor

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  Class 2 Device Recall White Acetal Titanium Rectal Retractor see related information
Date Initiated by Firm April 12, 2012
Date Posted January 31, 2013
Recall Status1 Terminated 3 on April 10, 2014
Recall Number Z-0760-2013
Recall Event ID 61879
510(K)Number K011657  
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
Product Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

Code Information All lots
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information Contact Pete Coronado
434-977-8495
Manufacturer Reason
for Recall		 A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAQ and Original Applicant = MICK RADIO-NUCLEAR INSTRUMENTS, INC.
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