Class 2 Device Recall

• Date Initiated by Firm: January 25, 2001
• Date Posted: December 21, 2004
• Recall Status: Terminated on December 21, 2004
• Recall Number: Z-0340-05
• Recall Event ID: 30641
• Product Classification: Cord, Electric, For Endoscope - Product Code FFZ
• Product: Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systems, Distributed by : Weck Closure Systems, One Weck Dr. Research Triangle Park, NC 27709, USA
• Code Information: Catalog #394236, Lot 3504519
• FEI Number: 3005747797
• Recalling Firm/ Manufacturer: Weck; 1 Weck Dr.; Research Triangle Park NC 27709
• For Additional Information Contact: Angela Tran; 919-361-4008
• Manufacturer Reason for Recall: An incorrect electrosurgical cord was included in some of the packages.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Consignees were notified by letter sent Federal Express on 01/25/2001.
• Quantity in Commerce: 462 units
• Distribution: Nationwide, 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.