Class 2 Device Recall LigaSure Blunt Tip Laparoscopic Sealer/Divider

• Date Initiated by Firm: December 08, 2010
• Date Posted: January 25, 2011
• Recall Status: Terminated on March 27, 2012
• Recall Number: Z-0954-2011
• Recall Event ID: 57498
• 510(K)Number: K092879
• Product Classification: electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
• Code Information: Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
• Recalling Firm/ Manufacturer: Covidien LP; 5920 Longbow Dr; Boulder CO 80301-3202
• For Additional Information Contact: 303-581-6773
• Manufacturer Reason for Recall: During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
• FDA Determined Cause: Device Design
• Action: The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).
• Quantity in Commerce: 25,009 units
• Distribution: Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, 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