Class 2 Device Recall GammaMed Plastic Needle with Mandrin

• Date Initiated by Firm: July 13, 2011
• Date Posted: August 10, 2011
• Recall Status: Terminated on June 20, 2012
• Recall Number: Z-2991-2011
• Recall Event ID: 59401
• 510(K)Number: K983436
• Product Classification: System, applicator, radionuclide, remote-controlled - Product Code JAQ
• Product: GammaMed Plastic Needle with Mandrin; 2.0mm diameter, length 113 mm. Remote controlled radionuclide applicator system. Varian Medical Systems, Inc. Mfg by Varian Medical Systems Haan GmbH, Haan, Germany Product Usage: 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 numbers GM11007560; All lots C01 to D01 and lots H and I
• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Michael Pignataro; 650-424-6471
• Manufacturer Reason for Recall: Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
• FDA Determined Cause: Device Design
• Action: Varian sent an "Urgent Medical Device Correction/Urgent Field Safety Notice" letter dated July 13, 2011 to all possibly affected customers. This notification supplements and modifies the previous "Customer Technical Bulletins" originally sent in September 2008. The initial Customer Technical Bulletins informed customers of the possibility that needle tips cans crack and separate. It also reminded users that the product has a limited life and to check needles prior to use as per instructions. Current correction notice letter instruct customers to stop using any plastic needles in inventory with lot numbers C01 to D01 and those with lot numbers starting with H or I. The letter also request that the recalled products be returned to Varian BrachyTherapy for replacement. The letters include information as to where the lot number is located on the device. All appropriate personnel should be notified of the correction notice. Contact information is provided for all geographical areas. USA contact for questions or concerns is 1-800-360-7909.
• Quantity in Commerce: 601 - all sizes.
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Austria, Bangladesh, Belgium, Brazil, Canada, Columbia, Cyprus, Czech Republic Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, India, Japan, Kazahastan, Kuwait, Lebanon, Macedonia, Mexico, Moldova, Nepal New Zealand, Norway, Pakistan, Philippines, Poland, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain Sweden, Switzerland, Taiwan, Thailand, Trinidad, Tobago, Turkey, Ukraine, United Arab Emirates Uruguay, United Kingdom, and Venezuela.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = JAQ