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U.S. Department of Health and Human Services

Class 2 Device Recall NonSterile Double DIN to DIN "Y" Connector

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  Class 2 Device Recall NonSterile Double DIN to DIN "Y" Connector see related information
Date Initiated by Firm January 20, 2015
Date Posted March 24, 2017
Recall Status1 Terminated 3 on March 30, 2017
Recall Number Z-1679-2017
Recall Event ID 76760
510(K)Number K003712  
Product Classification Accessories, blood circuit, hemodialysis - Product Code KOC
Product Non-Sterile Double DIN to DIN "Y" Connector,
Product Usage:
Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Code Information 40013
Recalling Firm/
Manufacturer		 Molded Products Inc
1112 Chatburn Ave
Harlan IA 51537-2007
For Additional Information Contact Sheri Tyrrel
712-755-5557
Manufacturer Reason
for Recall		 A customer relayed a complaint of a leaking dialysis tubing connector.
FDA Determined
Cause 2		 Process control
Action On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot.
Quantity in Commerce 400 pieces
Distribution Product was distributed to Ontario, Canada.
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.
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