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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 1see related information
Date Initiated by FirmSeptember 01, 2004
Date PostedJune 30, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall NumberZ-0600-2007
Recall Event ID 37017
510(K)NumberK022947 
Product Classification Perfusion System - Product Code DTQ
ProductTerumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040.
Code Information Serial numbers 0020 through 0899 may be affected. Serial numbers 0170, 0226 and 0739 have been corrected.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
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		Other
ActionThe 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 Commerce1,484 of both models
DistributionWorldwide: 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 CycleTPLC 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) Database510(K)s with Product Code = DTQ
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