Class 2 Device Recall Terumo Advanced Perfusion System 1

• Date Initiated by Firm: October 16, 2003
• Date Posted: November 07, 2003
• Recall Status: Terminated on July 07, 2005
• Recall Number: Z-0102-04
• Recall Event ID: 27604
• 510(K)Number: K022947
• Product Classification: Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
• Code Information: Serial numbers 0001 through 0599.
• 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 tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
• FDA Determined Cause: Other
• Action: Letters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.
• Quantity in Commerce: 285
• Distribution: United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.
• 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.