Class 2 Device Recall Terumo APS 1

• Date Initiated by Firm: May 01, 2004
• Date Posted: December 27, 2006
• Recall Status: Terminated on July 14, 2009
• Recall Number: Z-0315-2007
• Recall Event ID: 36395
• 510(K)Number: K022947
• Product Classification: cardiovascular perfusion system - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States).
• Code Information: Serial numbers 0040 through 0044.
• 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 gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
• FDA Determined Cause: Process control
• Action: U.S. consignees were visited and corrections made between May 2004 and November 2005. Foreign affiliates were instructed to make corrections on international units, but the firm has not received confirmation yet that these units have been corrected.
• Quantity in Commerce: 5
• Distribution: Worldwide distribution, including USA, Belgium, Germany, Japan, Korea and Republic of China.
• 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