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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 November 20, 2007
Date Posted January 29, 2009
Recall Status1 Terminated 3 on August 06, 2009
Recall Number Z-0674-2009
Recall Event ID 44850
510(K)Number K022947  
Product Classification Cardiopulmonary bypass heart-lung machine console - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Systems, Ann Arbor, MI; Model 801041.
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 number 0188.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 The system may malfunction due to t-filter corrosion on an internal circuit board.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action U.S. consignees were notified of the problem by letter on 11/16/07. International affiliates were informed via email on 11/21/07. Consignees were informed that Terumo would schedule appointments to install new pressure modules and reconfigure the systems beginning in Feb. 2008 or that parts would be shipped to consignees wishing to perform the work themselves. For additional information, contact Terumo CVS Customer Service at 1-800-521-2818.
Quantity in Commerce 1219 (total)
Distribution Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, 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.
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