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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 6 of 6 Results
510(K) Number: K173972
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2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis the... 2 12/20/2022 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX ... 2 04/20/2020 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/... 2 04/20/2020 FEI # 3001451489
Fresenius Medical Care Holdings, Inc.
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: ... 3 06/01/2019 FEI # 3001451489
Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Up... 2 09/19/2018 FEI # 3001451489
Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium U... 2 09/19/2018 FEI # 3001451489
Fresenius Medical Care Renal Therapies Group, LLC
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