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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 February 23, 2008
Recall Number Z-0931-2007
Recall Event ID 37242
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Code Information Serial number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.
Quantity in Commerce 1982 total for both models
Distribution Worldwide; USA, Australia, Belgium, Canada, Dominician Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, Pakistan, Republic of Georgia, Singapore, South Africa, Taiwan, Thailand 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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