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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo perfusion

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  Class 2 Device Recall Terumo perfusion see related information
Date Initiated by Firm July 01, 2004
Date Posting Updated July 07, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-1002-2007
Recall Event ID 37367
510(K)Number K915183  K953904  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
Code Information Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. Serial numbers 17525, 17697, 17899, 17904, 17905 and 17913 have been corrected.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-262-3304
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
Other
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 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 = 3M HEALTH CARE, LTD.
510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, SARNS
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