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Class 2 Device Recall Terumo Advanced Perfusion System 1 |
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Date Initiated by Firm |
October 16, 2003 |
Date Posted |
November 07, 2003 |
Recall Status1 |
Terminated 3 on July 07, 2005 |
Recall Number |
Z-0102-04 |
Recall Event ID |
27604 |
510(K)Number |
K022947
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Product Classification |
Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
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Product |
Terumo 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
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For Additional Information Contact |
800-521-2818
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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.
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FDA Determined Cause 2 |
Other |
Action |
Letters 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 Commerce |
285 |
Distribution |
United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Singapore, South Korea. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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