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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 41 Results
510(K) Number: K881330
 
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, REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicat... 2 03/12/2010 Sorin Group USA, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart P... 3 02/25/2016 Sorin Group USA, Inc.
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. 2 08/20/2013 Sorin Group USA, Inc.
Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way... 2 03/12/2010 Sorin Group USA, Inc.
Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 800... 2 03/12/2010 Sorin Group USA, Inc.
Perfusion Pack, Rx only, Sterile EO 2 01/23/2019 LivaNova USA
Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, ... 2 03/12/2010 Sorin Group USA, Inc.
Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, ... 2 03/12/2010 Sorin Group USA, Inc.
Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, ... 2 03/12/2010 Sorin Group USA, Inc.
Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, ... 2 03/12/2010 Sorin Group USA, Inc.
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