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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 September 10, 2007
Date Posted December 01, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0323-2008
Recall Event ID 38467
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Code Information Serial Numbers 0020 through 0041, 0043, 0044, 0046 through 0060, 0062 through 0091, 0094, 0098, 0118 through 0137, 0139 through 0156, 0159 and 0166 through 0176.
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		 Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.
FDA Determined
Cause 2		 Component change control
Action Consignees were notified via an Urgent Medical Device Correction letter dated 9/10/07, given instructions to follow if the problem were to manifest itself, and informed the firm would contact them to schedule an upgrade.
Quantity in Commerce 120
Distribution Nationwide.
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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