Class 2 Device Recall Circle C

• Date Initiated by Firm: May 28, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on January 12, 2005
• Recall Number: Z-1029-04
• Recall Event ID: 29253
• 510(K)Number: K941851
• Product Classification: Accessories, Blood Circuit, Hemodialysis - Product Code KOC
• Product: Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816, 1-800-472-5221. The product is a clear rigid plastic surgical tray containing components required for implantation. Components of the inner tray are in a separate sterile pouch. The tray and components are then sealed in an outer clear plastic pouch.
• Code Information: Catalog #DLC600-64C, Lot Numbers 335418 and 356778
• Recalling Firm/ Manufacturer: Horizon Medical Products Inc; 1 Horizon Way; Manchester GA 31816-1749
• For Additional Information Contact: Mary Gossard, M.S.; 800-782-9330 Ext. 3023
• Manufacturer Reason for Recall: The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter on 5/28/2004.
• Distribution: AL, CA, CO, FL, GA, IL, NJ, NY, OH, PA, SC, TN, TX & VA.
• 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 = KOC