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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAQ
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