• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo APS1Perfusion System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Terumo APS1Perfusion System
see related information
Date Posted January 09, 2007
Recall Status1 Terminated on February 01, 2007
Recall Number Z-0293-2007
Recall Event ID 36392
Premarket Notification
510(K) Numbers
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.
Code Information Serial number 3091 (correct) was labeled as serial number 0391 (incorrect).
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corp
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
An incorrect serial number was placed on one roller pump.
FDA Determined
Cause 2
DESIGN: Labeling Design
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 1
Distribution Worldwide-Michigan and Singapore.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
-
-