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January 29, 2010
Company:Edwards Lifesciences Inc.br>Date of Enforcement Report 1/11/2010 Class:l PRODUCT Edwards Lifesciences “Aquarius” System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010 This product was manufactured from July 12, 2007 through March 18, 2009 and distributed...
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