Class 2 Device Recall Electrode kit

• Date Initiated by Firm: July 16, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated on February 18, 2004
• Recall Number: Z-1122-03
• Recall Event ID: 26842
• 510(K)Number: K000079
• Product Classification: Apparatus, Electrosurgical - Product Code HAM
• Product: Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
• Code Information: Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520, CT-1530, CT-2020, CT-2030, CT-2530, CTC-1025, CTC-1525, CTC-2025.
• Recalling Firm/ Manufacturer: Valleylab, Inc; 5920 Longbow Drive; Boulder CO 80301
• For Additional Information Contact: 303-530-6241
• Manufacturer Reason for Recall: Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
• FDA Determined Cause: Other
• Action: Users were notified by letter on 7/16/2003.
• Quantity in Commerce: 10,000 kits
• Distribution: Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan.
• 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 = HAM