|
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 |
Diasol, Inc |
II |
Oct-23-2024 |
2 |
Diasol, Inc |
II |
Jun-18-2020 |
3 |
Fresenius Medical Care Holdings, Inc. |
II |
Nov-04-2022 |
4 |
Fresenius Medical Care Holdings, Inc. |
II |
Jul-12-2022 |
5 |
Fresenius Medical Care Holdings, Inc. |
II |
Jul-01-2022 |
6 |
Fresenius Medical Care Holdings, Inc. |
II |
Jul-16-2021 |
7 |
Fresenius Medical Care Holdings, Inc. |
II |
Feb-01-2021 |
8 |
Fresenius Medical Care Holdings, Inc. |
II |
Jan-11-2021 |
9 |
Fresenius Medical Care Holdings, Inc. |
II |
Jan-11-2021 |
10 |
Isopure Corp |
II |
Sep-13-2022 |
11 |
Isopure Corp |
II |
Jan-19-2020 |
12 |
Nipro Renal Soultions USA, Corporation |
II |
Jan-08-2025 |
13 |
NxStage Medical Inc |
II |
Jun-20-2024 |
|
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