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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS 1

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  Class 2 Device Recall Terumo APS 1 see related information
Date Initiated by Firm September 01, 2004
Date Posting Updated June 30, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0601-2007
Recall Event ID 37017
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041.
Code Information Serial numbers 0030 through 0998 may be affected. Serial numbers 0052, 0418, 0559, 0745 and 0767 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
The internal ribbon cable may loosen from the roller pump display board, resulting in loss of local control and/or local display.
FDA Determined
Cause 2
Action The firm corrected units in the field or brought them back for evaluation and repair as complaints were received between 9/04 and 4/06. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.
Quantity in Commerce 1,484 of both models
Distribution Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Mexico, Malaysia, Singapore, South Africa, Taiwan, Thailand 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.