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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Access & Return Line Set

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  Class 2 Device Recall Sterile Access & Return Line Set see related information
Date Initiated by Firm June 19, 2012
Date Posted March 18, 2013
Recall Status1 Terminated 3 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/
Molded Products Inc
1112 Chatburn Ave
Harlan IA 51537-2007
For Additional Information Contact Sheri Tyrrel
Manufacturer Reason
for Recall
The recalled product leaks at the connection site.
FDA Determined
Cause 2
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 and Original Applicant = MOLDED PRODUCTS INC.