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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 Device Recall Terumo APS 1 see related information
Date Initiated by Firm April 01, 2004
Date Posting Updated June 30, 2007
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-0923-2007
Recall Event ID 37244
510(K)Number K022947  
Product Classification Perfusion System - 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/
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
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
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 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 = TERUMO CARDIOVASCULAR SYSTEMS CORP.