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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 09, 2013
Date PostedOctober 24, 2013
Recall Status1 Terminated 3 on April 10, 2014
Recall NumberZ-0065-2014
Recall Event ID 66121
510(K)NumberK023220 
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
ProductVARISOURCE 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
FEI Number 3000206172
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information ContactMark 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
ActionUrgent Medical Device Correction, Urgent Field Safety Notice were mailed by FedEx tracked delivery to all consignees on August 12, 2013.
Quantity in Commerce3 sets
DistributionWorldwide distribution: US (nationwide) distribution in CA and in the country of India.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAQ
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