Class 3 Device Recall

• Date Initiated by Firm: May 21, 2003
• Date Posted: January 25, 2005
• Recall Status: Terminated on January 31, 2005
• Recall Number: Z-0418-05
• Recall Event ID: 30639
• Product Classification: Applier, Surgical, Clip - Product Code GDO
• Product: Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6'' 11 French, Rx Only, Sterile, Weck A Teleflex Company, Manufactured for: Weck Closure Systems, 2917 Weck Drive, Research Triangle park, NC 27709, USA.
• Code Information: Catalogue #809600, Lot #978933 & 978934
• 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: Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter sent via Federal Express on/about 05/21/2003.
• Quantity in Commerce: 667 units
• Distribution: Nationwide
• 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.