Class 2 Device Recall Weck Hemoclip Traditional Ligating Clips

• Date Initiated by Firm: October 24, 2003
• Date Posted: August 24, 2004
• Recall Status: Terminated on August 25, 2004
• Recall Number: Z-1390-04
• Recall Event ID: 29820
• Product Classification: Applier, Hemostatic Clip - Product Code HBT
• Product: Ref No. 523470 Hemoclip, 15 Large Stainless Steel Clips/Cartridge and Ref. No. 523670 Hemoclip, 10 Large Stainless Steel Clips/Cartridge
• Code Information: All lots manufactured between 2001-8 thorugh 2002-12 for 15 Large and 10 Large Stainless Steel Clips and lot 809026 for the 10 Large Stainless Steel Clips
• Recalling Firm/ Manufacturer: Weck; 1 Weck Dr.; Research Triangle Park NC 27709
• For Additional Information Contact: Angela Tran; 919-544-8000
• Manufacturer Reason for Recall: Hole in the sterile unit blister pack that could compromise sterility.
• FDA Determined Cause: Other
• Action: The consignees were notified of the recall via letter beginning October 24, 2003 asking for return of the product.
• Quantity in Commerce: 91,869 units for all products under recall
• Distribution: Nationwide and to accounts in Canada, Europe Asia, and South/Latin America
• 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.