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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 1 see related information
Date Initiated by Firm July 18, 2008
Date Posted November 06, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0204-2009
Recall Event ID 44851
510(K)Number K022947  
Product Classification Cardiopulmonary bypass heart-lung machine - Product Code DTQ
Product Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures.
Code Information Serial numbers 0006 through 0066, 0100 through 0322 and 1001 through 1017.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 The units may exhibit blank or distorted displays, loss of local control and/or may have local control knobs that are difficult to use.
FDA Determined
Cause 2		 Other
Action Consignees were notified via letter dated 7/18/08 and instructed to use the central control module should the problem occur. Contact Terumo Cardiovascular Systems Corp at 1-800-521-2818 for assistance.
Quantity in Commerce 300
Distribution Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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