Class 3 Device Recall Protg

• Date Initiated by Firm: April 15, 2003
• Date Posted: May 22, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-0863-03
• Recall Event ID: 26093
• 510(K)Number: K023243
• Product Classification: Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
• Product: Prot¿g¿ Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
• Code Information: Lot Number 132612
• Recalling Firm/ Manufacturer: ev3, Inc.; 651 Campus Drive; St. Paul MN 55112-3495
• For Additional Information Contact: Mitchell C. Muhich; 763-398-7000
• Manufacturer Reason for Recall: The label had an expiration date of August 2005, but the correct expiration date was February 2005.
• FDA Determined Cause: Other
• Action: A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.
• Quantity in Commerce: 15 units
• Distribution: Nationwide in United States.
• 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 = FGE and Original Applicant = SULZER INTRATHERAPEUTICS, INC.