Class 2 Device Recall APS 1

• Date Initiated by Firm: June 30, 2006
• Date Posted: August 22, 2006
• Recall Status: Terminated on June 19, 2008
• Recall Number: Z-1403-06
• Recall Event ID: 34487
• 510(K)Number: K022947
• Product Classification: Perfusion System - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041.
• Code Information: Serial numbers 0033 through 1263.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
• FDA Determined Cause: Other
• Action: The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.
• Quantity in Commerce: Recalls Z-1403-1405-2006- 1,135 systems in the U.S. plus 723 internationally.
• Distribution: Worldwide-USA, Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.
• 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