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U.S. Department of Health and Human Services

Class 2 Device Recall The Terumo Advanced Perfusion System 1

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 Class 2 Recall
The Terumo Advanced Perfusion System 1
see related information
Date Posted January 24, 2012
Recall Status1 Terminated on December 03, 2012
Recall Number Z-0840-2012
Recall Event ID 60463
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Information Catalog Number 816571; Serial Numbers 6621 - 6640
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
For Additional Information Contact Tracy Bellanca
734-741-6056
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (Terumo CVS) discovered and rejected a single digital encoder cable assembly during incoming inspection because it had a loose wire. The assembly is used in the 4" and the 6" roller pumps for the Terumo Advanced Perfusion System 1.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action TERUMO sent an Urgent Medical Device Correction letter dated January 13, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to 1-900-292-6551. Roller pumps with affected cables will have the cables assembly replaced. For questions regarding this recall call 1-800-521-2818.
Quantity in Commerce 44
Distribution Worldwide Distribution - USA including MD, WI, and IA and the countries of Canada, Mexico, and Vietnam
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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