Class 2 Device Recall Cooltip RFA Electrode Kits

• Date Initiated by Firm: August 01, 2012
• Date Posted: August 29, 2012
• Recall Status: Terminated on September 06, 2013
• Recall Number: Z-2301-2012
• Recall Event ID: 62705
• 510(K)Number: K030697 K973297
• Product Classification: Electrosurgical, cutting; coagulation; accessories - Product Code GEI
• Product: DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads); ; The product is used during ablation surgical procedures.
• Code Information: ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455; ; ; ; DGPHP, 162732 through, 214867X.
• Recalling Firm/ Manufacturer: Nellcor Puritan Bennett Inc. (dba Covidien LP); 6135 Gunbarrel Ave; Boulder CO 80301-3214
• For Additional Information Contact: Ms. Sandra DePonte; 203-492-8091
• Manufacturer Reason for Recall: Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
• FDA Determined Cause: Process control
• Action: The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 6, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine and discontinue use of the device; immediately advise all DGPHP RFA High-Power single use grounding pads and Cool-tip RF Electrode kit users of this recall; complete and return the attached Recalled Product Return Form in its entirety via fax to (800) 895-6140; return affected product to Covidien Attn: Field Returns Department, 195 McDermott Road, North Haven, CT 06473; if purchased directly from Covidien include completed form via fax or by email to : feedback.customerservice@covidien.com; if purchased from distributor complete form and contact your Distributor directly (completed form and all affected units must be returned through the Distributor); and reply to Covidien WHETHER OR NOT you have affect product at your site. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance, Monday through Friday, 8:30-5:00, directly at 203-492-5232.
• Quantity in Commerce: 184,934 units
• Distribution: Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
• 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 and Original Applicant = RADIONICS, INC.