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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 Recall
Sterile Access & Return Line Set
see related information
Date Posted March 18, 2013
Recall Status1 Terminated on August 14, 2013
Recall Number Z-0969-2013
Recall Event ID 64471
Premarket Notification
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, Iowa 51537-2007
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KOC and Original Applicant = MOLDED PRODUCTS INC.
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