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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo perfusion

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 Class 2 Recall
Terumo perfusion
see related information
Date Posted July 07, 2007
Recall Status1 Terminated on December 12, 2007
Recall Number Z-1004-2007
Recall Event ID 37367
Premarket Notification
510(K) Numbers
K900815  K915183  K953904 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395.
Code Information Serial numbers 10374, 10770, 11059, 13422, 15071, 17466 through 18062 may be affected by the problem. Serial numbers 17706, 17718, 17854, 17933, 17860, 17948, 17953 and 17954 have been corrected.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem.
Quantity in Commerce 728 pumps of all models
Distribution Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, 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 = 3M COMPANY
510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, LTD.
510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, SARNS
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