Class 2 Device Recall WECK Hemoclip

• Date Initiated by Firm: December 03, 2014
• Date Posted: December 17, 2014
• Recall Status: Terminated on November 24, 2017
• Recall Number: Z-0826-2015
• Recall Event ID: 69918
• 510(K)Number: K800079
• Product Classification: Clip, implantable - Product Code FZP
• Product: WECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
• Code Information: Product Code: 523300, Lot number: 01B1400034
• Recalling Firm/ Manufacturer: Teleflex Medical; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Karen Boylan; 919-433-4940
• Manufacturer Reason for Recall: The manufacturing dates and expiration dates were transposed on the Tyvek label.
• FDA Determined Cause: Labeling Change Control
• Action: Consignees were notified by letter on 12/03/2014.
• Quantity in Commerce: 3180 units
• Distribution: US (nationwide) including the states of AL, CA, FL, DE, IA, IL, IN, KY, MA, MN, NC, NE, NJ, NY, NV, OH, OK, PA, TX, VA, VT, and WA.
• 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 = FZP