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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 8 of 8 Results
Related Medical Device Recalls
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Product Description
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FDA Recall
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Z-1948-2020 - TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion... 2 05/11/2020 Cardiac Assist, Inc
Z-1949-2020 - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locall... 2 05/11/2020 Cardiac Assist, Inc
Z-1950-2020 - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to local... 2 05/11/2020 Cardiac Assist, Inc
Z-1955-2020 - TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver ... 2 05/11/2020 Cardiac Assist, Inc
Z-1952-2020 - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del... 2 05/11/2020 Cardiac Assist, Inc
Z-1953-2020 - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally ... 2 05/11/2020 Cardiac Assist, Inc
Z-1954-2020 - TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally de... 2 05/11/2020 Cardiac Assist, Inc
Z-1951-2020 - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del... 2 05/11/2020 Cardiac Assist, Inc
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