Date Initiated by Firm |
August 09, 2013 |
Date Posted |
October 24, 2013 |
Recall Status1 |
Terminated 3 on April 10, 2014 |
Recall Number |
Z-0065-2014 |
Recall Event ID |
66121 |
510(K)Number |
K023220
|
Product Classification |
System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
|
Product |
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA |
Code Information |
Lots #6078184-1, #6078184-2, #6078184-4 |
Recalling Firm/ Manufacturer |
Varian Medical Systems, Inc. 700 Harris St Ste 109 Charlottesville VA 22903-4584
|
For Additional Information Contact |
Mark Kattmann 434-977-8495
|
Manufacturer Reason for Recall |
The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Urgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013. |
Quantity in Commerce |
3 sets |
Distribution |
Worldwide distribution: US (nationwide) distribution in CA and in the country of India. |
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.
|
510(K) Database |
510(K)s with Product Code = JAQ and Original Applicant = VARIAN MEDICAL SYSTEMS
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