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Fresenius Medical Care Renal Therapies Group, LLC
FDA Regulatory Profile
Fresenius Medical Care Renal Therapies Group, LLC appears in FDA public data with 27 recalls, 51 510(k) clearances, 8 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-2151-2019, Class II) was initiated on May 29, 2019. Its most recent 510(k) clearance was granted on May 15, 2026.
Summary
- Total Recalls
- 27
- 510(k) Clearances
- 51
- Inspections
- 8
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2151-2019 | Class II | Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal di | May 29, 2019 |
| Z-1699-2019 | Class III | 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: | April 3, 2019 |
| Z-0658-2019 | Class II | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E | November 5, 2018 |
| Z-0517-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hem | October 9, 2018 |
| Z-0518-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for | October 9, 2018 |
| Z-0516-2019 | Class III | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hem | October 9, 2018 |
| Z-3194-2018 | Class II | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Up | July 13, 2018 |
| Z-3195-2018 | Class II | 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium U | July 13, 2018 |
| Z-2110-2018 | Class II | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 | May 2, 2018 |
| Z-1365-2018 | Class II | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indi | January 24, 2018 |
| D-0604-2018 | Class II | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC | December 20, 2017 |
| Z-1278-2018 | Class II | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PL | December 14, 2017 |
| D-0827-2018 | Class II | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltha | November 13, 2017 |
| Z-0829-2018 | Class II | 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. | October 5, 2017 |
| Z-1010-2018 | Class II | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concent | September 29, 2017 |
| Z-1028-2017 | Class II | Fresenius 2008K2 Series : Hemodialysis System | December 21, 2016 |
| Z-1029-2017 | Class II | Fresenius 2008K@home Series : Hemodialysis System | December 21, 2016 |
| Z-1026-2017 | Class II | Fresenius 2008T Series Hemodialysis System | December 21, 2016 |
| Z-1027-2017 | Class II | Fresenius 2008K Series : Hemodialysis System | December 21, 2016 |
| Z-2044-2016 | Class II | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-in | May 24, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252377 | NxStage System One with NxView | May 15, 2026 |
| K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | February 10, 2026 |
| K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | January 29, 2026 |
| K253518 | FX CorAL 40; FX CorAL 50 | December 18, 2025 |
| K250634 | BCM2-Body Composition Monitor | November 24, 2025 |
| K250471 | AquaC UNO H | November 14, 2025 |
| K251851 | DIASAFEplusUS (F00013010) | October 9, 2025 |
| K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP- | September 9, 2025 |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O | June 13, 2025 |
| K243505 | 5008X Hemodialysis System | May 30, 2025 |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP- | April 4, 2025 |
| K250404 | staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with L | April 3, 2025 |
| K242053 | FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) | March 21, 2025 |
| K243874 | FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972) | February 28, 2025 |
| K232953 | AquaBplus; AquaB LITE | June 13, 2024 |
| K240394 | multiFlux 1000 (F00012408) | May 31, 2024 |
| K233950 | pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F0001207 | May 10, 2024 |
| K232926 | Novalung ultimate kit (US) | April 15, 2024 |
| K231125 | 2008T BlueStar Hemodialysis Machine | December 6, 2023 |
| K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | December 1, 2023 |