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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 FirmApril 17, 2008
Date PostedDecember 29, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall NumberZ-0446-2009
Recall Event ID 44838
510(K)NumberK022947 
Product Classification cardiopulmonary bypass - Product Code DTQ
ProductTerumo 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
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
ActionTerumo 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 Commerce161
DistributionWorldwide 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 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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