| Class 2 Device Recall Terumo APS 1 | |
Date Initiated by Firm | April 17, 2008 |
Date Posted | December 29, 2008 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number | Z-0446-2009 |
Recall Event ID |
44838 |
510(K)Number | K022947 |
Product Classification |
cardiopulmonary bypass - Product Code DTQ
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Product | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). |
Code Information |
Serial numbers 0188 through 1027. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | 800-521-2818 |
Manufacturer Reason for Recall | The power supply may fail to charge the batteries due to various hardware malfunctions. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem. |
Quantity in Commerce | 161 |
Distribution | Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam. |
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
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