Class 2 Device Recall Terumo Advanced Perfusion System 1

• Date Initiated by Firm: September 10, 2007
• Date Posted: December 01, 2007
• Recall Status: Terminated on February 23, 2008
• Recall Number: Z-0321-2008
• Recall Event ID: 38466
• 510(K)Number: K022947
• Product Classification: Perfusion System - Product Code DTQ
• Product: Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
• Code Information: Serial Numbers 2110 through 2125.
• 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: Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.
• FDA Determined Cause: Process control
• Action: Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards.
• Quantity in Commerce: 16
• Distribution: Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong 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