Class 2 Device Recall IMA/ENT Blade Electrode

• Date Initiated by Firm: July 30, 2010
• Date Posted: September 27, 2010
• Recall Status: Terminated on April 21, 2011
• Recall Number: Z-2584-2010
• Recall Event ID: 56379
• Product Classification: Electrosurgical, cutting; coagulation and accessories - Product Code GEI
• Product: WECK IMA/ENT Blade Electrode ¿ (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC; The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.
• Code Information: Catalog number: 809335, Lot numbers: 2218273, 2227760, T1213320, T1214910, 01K0700276, 01L0700066, 01M0700224, 01E0800244, 0G0800102, 01G0800132, 01J0800040, 01J0800288, 01J0800376, 01K0800195, 01K0800281, 01L0800228 and 01D0900449.
• Recalling Firm/ Manufacturer: Telefelx Medical; 2917 Weck Drive; Durham NC 27709
• For Additional Information Contact: Angela Brown; 919-433-4901
• Manufacturer Reason for Recall: Complaints were received regarding peeling and melting of the insulation of the cautery tip of the IMA/ENT blade electrodes.
• FDA Determined Cause: Other
• Action: Teleflex Medical sent an "Urgent Medical Device Recall" letter dated July 30, 2010, to all customers. The letter described the product, problem and actions to be taken by customers. The customers were instructed to immediately discontinue use, quarantine any affected products and return all of the affected product to Teleflex Medical; forward the letter to their customers to retrieve product from those locations and complete and return the Recall Acknowledgement Form via fax at 1-866-804-9881. A second mailing to non-responding customers on the consignee list will be mailed approximately four to six seeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. Note: A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
• Quantity in Commerce: 190,344 eaches
• Distribution: Worldwide distribution: USA and countries of Canada, Australia and Singapore.
• 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.