Class 2 Device Recall Terumo perfusion

• Date Initiated by Firm: July 01, 2004
• Date Posted: July 07, 2007
• Recall Status: Terminated on December 12, 2007
• Recall Number: Z-1004-2007
• Recall Event ID: 37367
• 510(K)Number: K915183 K953904
• Product Classification: Perfusion System - Product Code DTQ
• Product: Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395.
• Code Information: Serial numbers 10374, 10770, 11059, 13422, 15071, 17466 through 18062 may be affected by the problem. Serial numbers 17706, 17718, 17854, 17933, 17860, 17948, 17953 and 17954 have been corrected.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corp; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 800-262-3304
• Manufacturer Reason for Recall: Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
• FDA Determined Cause: Other
• Action: As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem
• Quantity in Commerce: 728 pumps of all models
• Distribution: Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, 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; 510(K)s with Product Code = DTQ