Class 2 Device Recall Rita

• Date Initiated by Firm: September 21, 2005
• Date Posted: October 07, 2005
• Recall Status: Terminated on January 03, 2006
• Recall Number: Z-0031-06
• Recall Event ID: 33623
• 510(K)Number: K051420
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
• Code Information: Lot Number: 0011
• FEI Number: 1000523114
• Recalling Firm/ Manufacturer: Rita Medical Systems; 46421 Landing Parkway; Fremont CA 94538
• For Additional Information Contact: Linda Guthrie; 510-771-0440
• Manufacturer Reason for Recall: Devices for which sterility may be compromised as evidenced by a loss of package integrity.
• FDA Determined Cause: Other
• Action: On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.
• Distribution: Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
• 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