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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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 Class 2 Recall
Terumo APS 1
see related information
Date Posted November 06, 2008
Recall Status1 Terminated on July 07, 2009
Recall Number Z-0203-2009
Recall Event ID 44851
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
Code Information Serial numbers 0013 through 0610 and 1001 through 1026.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103
Manufacturer Reason
for Recall
The pumps may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified via letter dated 7/18/08 and instructed to use the central control module should the problem occur. Contact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.
Quantity in Commerce 626
Distribution Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
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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