Class 2 Device Recall Terumo perfusion

• Date Initiated by Firm: September 14, 2006
• Date Posted: December 07, 2006
• Recall Status: Terminated on June 19, 2008
• Recall Number: Z-0240-2007
• Recall Event ID: 36150
• 510(K)Number: K915183
• Product Classification: Perfusion system - Product Code DTW
• Product: Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409.
• Code Information: Serial numbers 1020, 1021, 1022, 1023, 1024, 1025 and 1026.
• 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 handle may separate and detach from the unit during use.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
• Quantity in Commerce: 7
• Distribution: Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand 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