|
Device |
dialysate concentrate for hemodialysis (liquid or powder) |
Regulation Description |
Hemodialysis system and accessories. |
Product Code | KPO |
Regulation Number |
876.5820
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Baxter Healthcare Corp. |
II |
Jun-24-2016 |
2 |
Diasol, Inc |
II |
Jun-18-2020 |
3 |
Fresenius Medical Care Holdings, Inc. |
II |
Feb-01-2021 |
4 |
Fresenius Medical Care Holdings, Inc. |
II |
Jan-11-2021 |
5 |
Fresenius Medical Care Holdings, Inc. |
II |
Jan-11-2021 |
6 |
Fresenius Medical Care Renal Therapies Group, LLC |
III |
Nov-29-2018 |
7 |
Fresenius Medical Care Renal Therapies Group, LLC |
II |
Jun-07-2018 |
8 |
Fresenius Medical Care Renal Therapies Group, LLC |
II |
Mar-14-2018 |
9 |
Fresenius Medical Care Renal Therapies Group, LLC |
II |
Feb-25-2016 |
10 |
Isopure Corp |
II |
Jan-19-2020 |
11 |
NxStage Medical, Inc. |
II |
Jun-02-2019 |
12 |
NxStage Medical, Inc. |
II |
Nov-27-2018 |
13 |
NxStage Medical, Inc. |
II |
Mar-19-2018 |
14 |
Rockwell Medical, Inc |
II |
May-14-2018 |
|
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