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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 1see related information
Date Initiated by FirmApril 01, 2004
Date PostedJune 30, 2007
Recall Status1 Terminated 3 on June 11, 2008
Recall NumberZ-0924-2007
Recall Event ID 37244
510(K)NumberK022947 
Product Classification Perfusion System - Product Code DTQ
ProductTerumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Code Information Serial numbers 0033 through 0355 are potentially affected by the problem. Serial numbers 0033, 0041, 0049, 0052, 0105, 0115, 0117, 0119, 0122, 0145, 0151, 0159, 0160, 0161, 0162, 0170, 0174, 0218, 0226, 0242, 0257, 0262, 0277, 0279, 0290, 0299, 0300, 0305, 0306, 0331, 0334, 0339, 0343 and 0360 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		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		Other
ActionThe 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 Commerce525 total for both models
DistributionWorldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore 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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