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U.S. Department of Health and Human Services

Class 3 Device Recall Sarns" Modular Perfusion System 8000

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 Class 3 Recall
Sarns" Modular Perfusion System 8000
see related information
Date Posted August 16, 2012
Recall Status1 Terminated on November 07, 2012
Recall Number Z-2218-2012
Recall Event ID 62732
Premarket Notification
510(K) Number
K915183 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Information catalog number: 16401 and serial number: 2001, 2002, and 2003.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.
Quantity in Commerce 3
Distribution US Nationwide Distribution - including the state of New York
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 = 3M HEALTH CARE, SARNS
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