Class 2 Device Recall Terumo Perfusion System 8000

• Date Initiated by Firm: January 12, 2007
• Date Posted: March 27, 2007
• Recall Status: Terminated on June 19, 2008
• Recall Number: Z-0658-2007
• Recall Event ID: 37366
• 510(K)Number: K900815
• Product Classification: Perfusion System - Product Code DTW
• Product: Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
• Code Information: Hand crank serial numbers 1197 through 1214.
• 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 hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
• FDA Determined Cause: Other
• Action: Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
• Quantity in Commerce: 18
• Distribution: Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan 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 = DTW