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-0325-2007
• Recall Event ID: 36396
• 510(K)Number: K022947
• Product Classification: Perfusion System - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
• Code Information: Serial numbers 0033, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136, 0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015, 1017, 1019 and 1024 through 1027.
• 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: 4,740 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