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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0760-2012 - Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0761-2012 - Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0762-2012 - Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord,...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0763-2012 - Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86,...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0764-2012 - Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 No...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0771-2012 - PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004 (utilizing oxygenators manufactured by: Sorin Group Italia, Via ...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0766-2012 - D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord,...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0767-2012 - D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 8...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0768-2012 - PRIMO2X Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86,...
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2
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01/14/2012
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Sorin Group USA, Inc.
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Z-0769-2012 - SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.
...
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2
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01/14/2012
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Sorin Group USA, Inc.
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