Class 2 Device Recall Terumo APS 1

• Date Initiated by Firm: July 18, 2008
• Date Posted: October 31, 2008
• Recall Status: Terminated 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/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: Local pump controls including start/stop button, select button and manual button may not function.
• FDA Determined Cause: 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