Class 2 Device Recall Terumo APS1Perfusion System

• Date Initiated by Firm: October 06, 2005
• Date Posted: January 09, 2007
• Recall Status: Terminated on February 01, 2007
• Recall Number: Z-0293-2007
• Recall Event ID: 36392
• 510(K)Number: K022947
• Product Classification: Perfusion System - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
• Code Information: Serial number 0391(correct) was labeled as serial number 3091 (incorrect).
• 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: An incorrect serial number was placed on one roller pump.
• FDA Determined Cause: Other
• Action: The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
• Quantity in Commerce: 1
• Distribution: Worldwide-Michigan and Singapore.
• 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