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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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  Class 2 Device Recall Terumo APS 1 see related information
Date Initiated by Firm July 18, 2008
Date Posted October 31, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0206-2009
Recall Event ID 44852
510(K)Number K022947  
Product Classification Cardiopulmonary bypass heart-lung machine console. - Product Code DTQ
Product Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States.

For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
Code Information Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103
For Additional Information Contact
Manufacturer Reason
for Recall
Local pump controls including start/stop button, select button and manual button may not function.
FDA Determined
Cause 2
Component design/selection
Action Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.
Quantity in Commerce 300
Distribution Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, 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 and Viet Nam.
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 = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.