GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 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.
This recall has been terminated (originally issued December 1, 2011).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- September 30, 2008
- Posted
- December 1, 2011
- Terminated
- December 7, 2011
- Recall Number
- Z-0326-2012
- Quantity
- 1716 parts
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Plastic needle tip could possibly crack or separate.
Distribution
Worldwide 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.
Lot / Code Info
Part number GM11007560
Root Cause
Nonconforming Material/Component
Action Taken
Varian 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.