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/ 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 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.
|