Recall Z-0327-2012
Varian Medical Systems, Inc. · initiated September 30, 2008
Product
GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 200 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.
Codes / lots: Part number GM11007570
Reason for recall
Plastic needle tip could possibly crack or separate.
FDA-determined 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.
Details
- Recall number
- Z-0327-2012
- Initiated
- September 30, 2008
- Posted by FDA
- December 1, 2011
- Terminated
- December 7, 2011
- Product code
- JAQ – System, Applicator, Radionuclide, Remote-Controlled
- Quantity
- 1716 parts
- 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.
- Recalling firm
- Varian Medical Systems, Inc., Charlottesville, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0326-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 113 mm. Remote controlled…Plastic needle tip could possibly crack or separate. | 09/30/2008Terminated |
| Z-0328-2012 | GammaMed Plastic Needle with Mandrin; 2.0 mm diameter, length 320 mm. Remote controlled…Plastic needle tip could possibly crack or separate. | 09/30/2008Terminated |