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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-1023-2023 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
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Z-1024-2023 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
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Z-1028-2023 - Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
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Z-1026-2023 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
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Z-1027-2023 - Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
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Z-1025-2023 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
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2
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01/27/2023
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Medtronic Perfusion Systems
|