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Fresenius Medical Care Renal Therapies Group, LLC

Last updated September 17, 2026

Information

Country: US
Address: 920 WINTER STREET, Waltham, MA, 02451
Website: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001451489
DUNS Number: —

Catalogue (130)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Optiflux Series of Dialyzers F160NR, F180NR, F200NR	K203062	FDA 510(k)	Class II	Active
Cycler Drain Bag Set	K173363	FDA 510(k)	Class II	Active
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate	K212620	FDA 510(k)	Class II	Active
bibag	K162716	FDA 510(k)	Class II	Active
2008T BlueStar Hemodialysis Machine	K173972	FDA 510(k)	Class II	Active
Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set	K173651	FDA 510(k)	Class II	Active
Liberty Cycler Set	K173718	FDA 510(k)	Class II	Active
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine	K150708	FDA 510(k)	Class II	Active
DIASAFEplusUS	K182367	FDA 510(k)	Class II	Active
CRIT-LINE III Blood Chamber II	K160749	FDA 510(k)	Class II	Active
Hemoflow F3 and F4 Dialyzers	K190459	FDA 510(k)	Class II	Active
FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)	K242053	FDA 510(k)	Class II	Active
Lilliput APD System	K212522	FDA 510(k)	Class II	Active
CAREline Airless Hemodialysis Blood Tubing Sets	K172238	FDA 510(k)	Class II	Active
2008T BlueStar Hemodialysis Machine	K231125	FDA 510(k)	Class II	Active
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504	K233159	FDA 510(k)	Class II	Active
Novalung ultimate kit (US)	K232926	FDA 510(k)	Class II	Active
Novalung System	K191407	FDA 510(k)	Class II	Active
NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)	K191474	FDA 510(k)	Class II	Active
Liberty Pdx Cycler	K141145	FDA 510(k)	Class II	Active
AquaC UNO H	K250471	FDA 510(k)	Class II	Active
multiFlux 1000 (F00012408)	K240394	FDA 510(k)	Class II	Active
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch	K173593	FDA 510(k)	Class II	Active
multiFlux 130 (F00013123); multiFlux 160 (F00013124)	K252459	FDA 510(k)	Class II	Active
2008t Hemodialysis Machine With Optional Crit-Line Monitor (clic)	K131908	FDA 510(k)	Class II	Active
Optiflux F180NR Dialyzer	K192707	FDA 510(k)	Class II	Active
FX CorAL 40; FX CorAL 50	K253518	FDA 510(k)	Class II	Active
Optiflux Enexa F500 Dialyzer	K192928	FDA 510(k)	Class II	Active
stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch	K250404	FDA 510(k)	Class II	Active
Crit-Line Clip (clic) Blood Chamber	K141281	FDA 510(k)	Class II	Active

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FDA Recalls (25)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 29, 2019	Z-2151-2019	—	terminated	Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
Apr 3, 2019	Z-1699-2019	—	terminated	Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
Nov 5, 2018	Z-0658-2019	—	terminated	Potential for external blood leaks from the dialyzer header
Oct 9, 2018	Z-0518-2019	—	terminated	Discolored powder has confirmed the presence of a foreign substance
Oct 9, 2018	Z-0516-2019	—	terminated	Discolored powder has confirmed the presence of a foreign substance
Oct 9, 2018	Z-0517-2019	—	terminated	Discolored powder has confirmed the presence of a foreign substance
Jul 13, 2018	Z-3195-2018	—	terminated	In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
Jul 13, 2018	Z-3194-2018	—	terminated	In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before starting a treatment and disinfectant could exist in the dialysate delivered to the patient.
May 2, 2018	Z-2110-2018	—	terminated	The bottles are mislabeled with an incorrect part number.
Jan 24, 2018	Z-1365-2018	—	terminated	The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
Dec 14, 2017	Z-1278-2018	—	terminated	When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.
Oct 5, 2017	Z-0829-2018	—	terminated	While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
Sep 29, 2017	Z-1010-2018	—	terminated	The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.
Dec 21, 2016	Z-1028-2017	—	terminated	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Dec 21, 2016	Z-1029-2017	—	terminated	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Dec 21, 2016	Z-1026-2017	—	terminated	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Dec 21, 2016	Z-1027-2017	—	terminated	When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
May 24, 2016	Z-2044-2016	—	terminated	Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Mar 10, 2016	Z-1325-2016	—	terminated	Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Feb 26, 2016	Z-1324-2016	—	terminated	Dialyzer header leak due to possible improper torque
Jan 18, 2016	Z-0887-2016	—	terminated	On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Dec 15, 2015	Z-0693-2016	—	terminated	The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
Oct 23, 2015	Z-0295-2016	—	terminated	Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Oct 23, 2015	Z-0294-2016	—	terminated	Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Oct 23, 2015	Z-0296-2016	—	terminated	Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.