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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS1Perfusion System

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  Class 2 Device Recall Terumo APS1Perfusion System see related information
Date Initiated by Firm October 06, 2005
Date Posted January 09, 2007
Recall Status1 Terminated 3 on February 01, 2007
Recall Number Z-0292-2007
Recall Event ID 36392
510(K)Number K022947  
Product Classification Perfusion System - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Code Information Serial numbers 0976 and 0979.
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		 Six inch roller pumps were mislabeled as 4 inch roller pumps.
FDA Determined
Cause 2		 Other
Action The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
Quantity in Commerce 2
Distribution Worldwide-Michigan and Singapore.
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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