Class 2 Device Recall RITA Main Cable

• Date Initiated by Firm: June 11, 2013
• Date Posted: July 10, 2013
• Recall Status: Terminated on June 12, 2015
• Recall Number: Z-1675-2013
• Recall Event ID: 65439
• 510(K)Number: K040989
• Product Classification: Electrosurgical, cutting & coagulation &accessories - Product Code GEI
• Product: AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
• Code Information: Catalog #700-101892, Lot number: 30.12
• Recalling Firm/ Manufacturer: Angiodynamics, INC; 1 Horizon Way; Manchester GA 31816-1749
• For Additional Information Contact: Mark Frost; 518-795-1981
• Manufacturer Reason for Recall: The RITA Main Cable product contains the incorrect Instructions for Use.
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified via certified mail on 06/11/2013 with an "Urgent Medical Device Field Safety Correction" notification. This included the correct Instructions for Use and the recommended actions.
• Quantity in Commerce: 13 units
• Distribution: Worldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
• 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 = GEI