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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed Plastic Needle with Mandrin

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 Class 2 Device Recall GammaMed Plastic Needle with Mandrinsee related information
Date Initiated by FirmSeptember 30, 2008
Date PostedDecember 01, 2011
Recall Status1 Terminated 3 on December 07, 2011
Recall NumberZ-0328-2012
Recall Event ID 59779
510(K)NumberK983436 
Product Classification System, applicator, radionuclide, remote-controlled - Product Code JAQ
ProductGammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany. The interstitial plastic needles with 2 mm diameter are designed for interstitial treatments in areas such as head and neck, gynecology, breast or prostate. In order to avoid bending and to facilitate the introduction of the needles, each needle is supplied with a mandrin.
Code Information Part number GM11007580
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
700 Harris St Ste 109
Charlottesville VA 22903-4584
For Additional Information ContactMark Kattmann
434-977-8495 Ext. 232
Manufacturer Reason
for Recall		Plastic needle tip could possibly crack or separate.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionVarian Medical Systems sent a "CUSTOMER TECHNICAL BULLETIN" letter dated September 30, 2008 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed users to inspect needle tips before and after every clinical application to prevent needle tip separation or cracking.
Quantity in Commerce1716 parts
DistributionWorldwide Distribution - USA (nationwide) including the states of Arizonia, California, Florida, Illinois, Indiana, Michigan, North Carolina, and Vermont, and the countries of Argentina, Austria, Belgium, Canada, Estonia, France, Germany, India, Norway, Pakistan, Russia, Slovenia, So. Africia, Spain, Switzerland, United Kingdom, and Ukraine.
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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