Class 3 Device Recall

• Date Initiated by Firm: October 31, 2001
• Date Posted: January 13, 2005
• Recall Status: Terminated on January 31, 2005
• Recall Number: Z-0393-05
• Recall Event ID: 30640
• Product Classification: Applier, Surgical, Clip - Product Code GDO
• Product: Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.
• Code Information: Catalog #544965, Lot #694505 & 694506
• 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: The flush port on some appliers was occluded with an epoxy resin during manufacturing.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 10/31/2001.
• Quantity in Commerce: 66 units
• Distribution: AL, AZ, CA,CO, CT, FL,GA, KS, NC, NH, NJ, NY, TN, TX, VA,WA.Australia, Singapore, 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.