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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 July 09, 2012
Recall Status1 Terminated on February 19, 2013
Recall Number Z-1962-2012
Recall Event ID 61231
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
Code Information catalog number: 801188 and Serial numbers: 0001-0006, 0008-00050, 00052-00123,00125-00152, 00154-0174,00176-00211, 00213-00241, 00245-00250, 00300-00356, 00358-00365, 00367-00449, 00451-00489, 00492-00522, 00524-00531, 00533-00649, 00651-00660, 00662-00825,0826-0830, 00831-01157, and 01160-01164.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL-SAFETY ADVISORY" letter dated June 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
Quantity in Commerce 1095 Units
Distribution Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
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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