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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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 Class 2 Recall
Terumo Advanced Perfusion System 1
see related information
Date Posted September 24, 2012
Recall Status1 Terminated on January 13, 2014
Recall Number Z-2443-2012
Recall Event ID 62313
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Code Information Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
Action Terumo CVS issued an URGENT MEDICAL DEVICE Recall letter dated September 10, 2012 to alert all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Terumo CVS representative will contact all affected US account.to schedule an appointment to replace the affected product. The affected product will be return to Terumo for destruction. Non-US Terumo Affiliates will be instructed to remove the devices from the field and provide a record of destruction. For questions call the Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 150 units
Distribution Worldwide and US Nationwide Distribution
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 = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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