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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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 Class 2 Device Recall Terumo Advanced Perfusion System 1see related information
Date Initiated by FirmOctober 16, 2003
Date PostedNovember 07, 2003
Recall Status1 Terminated 3 on July 07, 2005
Recall NumberZ-0102-04
Recall Event ID 27604
510(K)NumberK022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
ProductTerumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
Code Information Serial numbers 0001 through 0599.
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 roller pump tube clamp mechanism may fail to release , making it difficult to remove or insert the tubing, and thereby delaying perfusion.
FDA Determined
Cause 2
Other
ActionLetters entitled Urgent Safety Alerts were sent to each customer on 10/16/03. Customers were made away of the problem and advised to develop a protocol for action, in case the problem occurred in their facility.
Quantity in Commerce285
DistributionUnited States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea.
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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