Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2026, with 33 FDA device recalls on record.
Top product codes for Fresenius Medical Care Renal Therapies Group, LLC
FDA recalls by Fresenius Medical Care Renal Therapies Group, LLC
10 most recent of 33- Z-3087-2026 — 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Z-3084-2026 — 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
- Z-3085-2026 — 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
- Z-3086-2026 — 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
- Z-3091-2026 — GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- Z-3092-2026 — NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- Z-3093-2026 — Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- Z-3017-2026 — Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
- Z-2151-2019 — Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216
- Z-1699-2019 — 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fresenius Medical Care Renal Therapies Group, LLC
- K261267 — Careflux H60; Careflux H70; Careflux V500
- K252377 — NxStage System One with NxView
- K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124)
- K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- K253518 — FX CorAL 40; FX CorAL 50
- K250634 — BCM2-Body Composition Monitor
- K250471 — AquaC UNO H
- K251851 — DIASAFEplusUS (F00013010)
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W) +7 more
- K243237 — 2008T HD SYS. CDX BLUESTAR (191124) +3 more
- K243505 — 5008X Hemodialysis System
- K243786 — Bicarby Dialysate RFP-402 (RFP-402-G) +7 more
- K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch +4 more
- K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)
- K243874 — FX CorAL 60 (F00012969) +6 more
- K232953 — AquaBplus; AquaB LITE
- K240394 — multiFlux 1000 (F00012408)
- K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- K232926 — Novalung ultimate kit (US)
- K231125 — 2008T BlueStar Hemodialysis Machine
- K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
- K213992 — CombiSet Hemodialysis Blood Tubing Set
- K220721 — FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
- K220281 — multiFiltratePRO System
- K222318 — Fresenius Liberty Select Cycler
- K222952 — 2008T BlueStar Hemodailysis Machine
- K212620 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K212522 — Lilliput APD System
- K203062 — Optiflux Series of Dialyzers F160NR, F180NR, F200NR
- K192707 — Optiflux F180NR Dialyzer
- K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
- K192209 — Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
- K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K191474 — NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
- K191407 — Novalung System
- K190459 — Hemoflow F3 and F4 Dialyzers
- K182367 — DIASAFEplusUS
- K181108 — Fresenius Liberty Select Cycler
- K173593 — staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
- K173972 — 2008T BlueStar Hemodialysis Machine
- K173718 — Liberty Cycler Set
- K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
- K173363 — Cycler Drain Bag Set
- K172238 — CAREline Airless Hemodialysis Blood Tubing Sets
- K171652 — Fresenius Liberty Select Cycler
- K162716 — bibag
- K153449 — 2008K2 Hemodialysis Machine
- K160749 — CRIT-LINE III Blood Chamber II
- K150708 — 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
- K141145 — LIBERTY PDX CYCLER
- K131908 — 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
Data sourced from openFDA. This site is unofficial and independent of the FDA.