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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
510(K) Number: K110493
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Product Description
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FDA Recall
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TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circula... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Us... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product U... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: prov... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: ... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usag... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage:... 2 05/11/2020 Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: ... 2 05/11/2020 Cardiac Assist, Inc
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