Class 2 Device Recall Terumo APS 1

• Date Initiated by Firm: October 12, 2004
• Date Posted: December 30, 2006
• Recall Status: Terminated on February 01, 2007
• Recall Number: Z-324-2007
• Recall Event ID: 36396
• 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 numbers 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0117, 0120-0123, 0125-0131, 0133-0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204, 0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903, 0906 through 0912, 0922 and 0924.
• 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: Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
• FDA Determined Cause: Other
• Action: U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.
• Quantity in Commerce: 4740 for all affected products
• Distribution: Worldwide Distribution-USA and countries 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 = DTQ