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U.S. Department of Health and Human Services

Class 2 Device Recall APS 1

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  Class 2 Device Recall APS 1 see related information
Date Initiated by Firm June 30, 2006
Date Posted August 22, 2006
Recall Status1 Terminated 3 on June 19, 2008
Recall Number Z-1404-06
Recall Event ID 34487
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Roller Pump 4 inch diameter; Catalog No. 801040.
Code Information Serial numbers 0031 through 1025.
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 roller pump speed control knobs and the centrifugal pump speed control knobs may fail to function/change pump speed.
FDA Determined
Cause 2		 Other
Action The firm replaced the graphics driver board on complaint units as user complaints were received. The firm notified all users of the problem and the presence of an alternative method of pump speed control via recall letter dated 6/30/06.
Quantity in Commerce Recall Numbers Z-1403-1405-2006 -1,135 systems in the U.S. plus 723 internationally.
Distribution Worldwide-USA, 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 and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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