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 and Original Applicant = EDWARD WECK, INC.