Class 2 Device Recall Electrosurgery Accessory

• Date Initiated by Firm: January 27, 2006
• Date Posted: April 19, 2006
• Recall Status: Terminated on August 15, 2008
• Recall Number: Z-0773-06
• Recall Event ID: 34573
• 510(K)Number: K010013
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
• Code Information: Catalog Number LS1120. Lot numbers: Any lot number beginning with N2, N3, N4, or N5A through N5L235K.
• Recalling Firm/ Manufacturer: Covidien LP; 5920 Longbow Dr; Boulder CO 80301-3202
• For Additional Information Contact: 303-581-6773
• Manufacturer Reason for Recall: Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 01/27/2006.
• Quantity in Commerce: 123,000 units domestic, 126,000 units internationally.
• Distribution: Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.
• 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 = VALLEYLAB, INC.