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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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 Class 2 Recall
Terumo Advanced Perfusion System 1
see related information
Date Posted December 01, 2007
Recall Status1 Terminated on February 23, 2008
Recall Number Z-0321-2008
Recall Event ID 38466
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Code Information Serial Numbers 2110 through 2125.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Failure to operate; The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, which provided them guidance in the event the problem occurs and advised them they would be contacted to schedule replacement of the circuit boards.
Quantity in Commerce 16
Distribution Worldwide Distribution-USA including states of Alabama, Arizona, Florida, Illinois, Indiana, Mississippi, Nebraska, North Carolina, Pennsylvania, and Virginia, and countries of Belgium, Hong Kong and United Arab Emirates.
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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