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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1 Flow Module

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 Class 2 Device Recall Terumo Advanced Perfusion System 1 Flow Modulesee related information
Date Initiated by FirmSeptember 20, 2012
Date PostedSeptember 25, 2012
Recall Status1 Terminated 3 on January 13, 2014
Recall NumberZ-2449-2012
Recall Event ID 62322
510(K)NumberK022947 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Flow Module 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: 00122,00132, 00137, 00321-00337, 00339, 00340, 00342-00389,00391-00439, 00441, 00442, 00444-00455, 00457, 00459, 00460, 00466, 00467, 00475, and 00488.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
FDA Determined
Cause 2		Process control
ActionTERUMO sent an Urgent Medical Device Recall letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; and confirm receipt of the communication by faxing the attached Customerr Resonse Form to 1-734-741-6149. Terumo CVS will send a representative to each affected US account to replace the affected devices and return the affected devices 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 question customers should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.
Quantity in Commerce72 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTQ
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