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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 FirmApril 14, 2005
Date PostedJune 22, 2005
Recall Status1 Terminated 3 on August 22, 2005
Recall NumberZ-0921-05
Recall Event ID 31941
510(K)NumberK983436 
Product Classification System, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
ProductFlexible Implant tube, blind end, 350 mm, part # GM11003730, labeled in part ***Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304 USA www.varian.com***. Available as single unit or contained in the Flexible Interstitial Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device.
Code Information Lot 04/21/1
FEI Number 3000206172
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris Street
Suite 109
Charlottesville VA 22903-4584
For Additional Information ContactBrachytherapy Technical Support
866-385-1322
Manufacturer Reason
for Recall		A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
FDA Determined
Cause 2		Other
ActionThe recalling firm notified end users by Customer Technical Bulletin on 4/14/05. The bulletin advised of potential for the blind end of the implant tube to become separated with the possible effect of the tube end being inhaled by a patient. Consignees were instructed to stop using product and return for replacement. The firm''s bulletin is also available on the company website.
Quantity in Commerce33 devices in domestic distribution
DistributionProduct was distributed to direct accounts in CT, MI, PA, CO, VT and MO. Product was additionally sold to foreign accounts in internationally.
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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