Class 2 Device Recall Sterile Access & Return Line Set

• Date Initiated by Firm: June 19, 2012
• Date Posted: March 18, 2013
• Recall Status: Terminated on August 14, 2013
• Recall Number: Z-0969-2013
• Recall Event ID: 64471
• 510(K)Number: K003712
• Product Classification: Accessories, blood circuit, hemodialysis - Product Code KOC
• Product: Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
• Code Information: Lot numbers: 80106 and 80106b
• Recalling Firm/ Manufacturer: Molded Products Inc; 1112 Chatburn Ave; Harlan IA 51537-2007
• For Additional Information Contact: Sheri Tyrrel; 800-435-8957
• Manufacturer Reason for Recall: The recalled product leaks at the connection site.
• FDA Determined Cause: Process control
• Action: The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.
• Quantity in Commerce: 1200 sets
• Distribution: Distributed to one customer in Michigan.
• 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