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U.S. Department of Health and Human Services

Class 3 Device Recall Terumo APS 1

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 Class 3 Recall
Terumo APS 1
see related information
Date Posted June 30, 2007
Recall Status1 Terminated on June 11, 2008
Recall Number Z-0923-2007
Recall Event ID 37244
Premarket Notification
510(K) Number
K022947 
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 numbers 0031 through 0324 are potentially affected by the problem. Serial numbers 0092, 0128, 0152, 0223, 0226, 0237, 0246, 0260 and 0296 have been corrected.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.
Quantity in Commerce 525 total for both models
Distribution Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore 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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