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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS1Perfusion System

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 Class 2 Recall
Terumo APS1Perfusion System
see related information
Date Posted January 09, 2007
Recall Status1 Terminated on February 01, 2007
Recall Number Z-0293-2007
Recall Event ID 36392
Premarket Notification
510(K) Numbers
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Code Information Serial number 3091 (correct) was labeled as serial number 0391 (incorrect).
Recalling Firm/
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
An incorrect serial number was placed on one roller pump.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
Quantity in Commerce 1
Distribution Worldwide-Michigan and Singapore.
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.