Class 2 Device Recall Terumo APS 1

• Date Initiated by Firm: April 17, 2008
• Date Posted: December 29, 2008
• Recall Status: Terminated on July 07, 2009
• Recall Number: Z-0445-2009
• Recall Event ID: 44838
• 510(K)Number: K022947
• Product Classification: cardiopulmonary bypass - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
• Code Information: Serial numbers 0396 through 1049.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Road; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-521-2818
• Manufacturer Reason for Recall: The power supply may fail to charge the batteries due to various hardware malfunctions.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.
• Quantity in Commerce: 256
• Distribution: Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, 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