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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: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001451489
DUNS Number: —

Catalogue (130)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw	03-5150-2	FDA UDI	Class II	Active
NaturaLyte	13-2201-5	FDA UDI	Class II	Active
Citrasate Dry	0FD2231-DA	FDA UDI	Class II	Active
Citrasate	13-2251-CA	FDA UDI	Class II	Active
GranuFlo	0FD3201-3B	FDA UDI	Class II	Active
Citrasate Dry	0FD1251-DA	FDA UDI	Class II	Active
Citrasate Dry	0FD2301-DA	FDA UDI	Class II	Active
Bicarby	RFP-404-G	FDA UDI	Class II	Active
Citrasate Dry	0FD3231-DA	FDA UDI	Class II	Active
Citrasate Dry	0FD3301-DA	FDA UDI	Class II	Active
GranuFlo	0FD2231-3B	FDA UDI	Class II	Active
PureFlow	RFP-407-W	FDA UDI	Class II	Active
CAREline	0342006	FDA UDI	Class II	Unknown
NaturaLyte	08-1001-0	FDA UDI	Class II	Active
PureFlow	RFP-400-W	FDA UDI	Class II	Active
NaturaLyte	08-1301-4	FDA UDI	Class II	Active
NaturaLyte	08-0231-4	FDA UDI	Class II	Active
Liberty	050-87216A	FDA UDI	Class II	Active
Bicarby	RFP-401-G	FDA UDI	Class II	Active
GranuFlo	0FD3301-3B	FDA UDI	Class II	Active
5008x	03-5110-6	FDA UDI	Class II	Active
5008x	03-5300-3	FDA UDI	Class II	Active
5008X Fluid Sampling Accessory	04-9009-4	FDA UDI	Class II	Active
NaturaLyte	13-2231-2	FDA UDI	Class II	Active
5008x	03-5160-1	FDA UDI	Class II	Active
GranuFlo	0FD2301-3B	FDA UDI	Class II	Active
Bicarby	RFP-407-G	FDA UDI	Class II	Active
Bicarby	RFP-456-G	FDA UDI	Class II	Active
5008x	03-5300-3C	FDA UDI	Class II	Active
5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber	03-5100-7C	FDA UDI	Class II	Active
Citrasate	13-3251-CA	FDA UDI	Class II	Active
Citrasate	08-2251-CA	FDA UDI	Class II	Active
NaturaLyte	08-2301-3	FDA UDI	Class II	Active
5008X Hemodialysis Machine	M204441	FDA UDI	Class II	Active
CitraSure™	28-0600-0	FDA UDI	Class II	Active
Liberty	050-87215A	FDA UDI	Class II	Active
Citrasate	08-3251-CA	FDA UDI	Class II	Active
NaturaLyte	08-3301-2	FDA UDI	Class II	Active
CombiSet SMARTECH	03-2742-9C	FDA UDI	Class II	Active
GranuFlo	0FD2251-3B	FDA UDI	Class II	Active
NaturaLyte	08-1201-8	FDA UDI	Class II	Active
5008X HDF Hemodialysis Blood Tubing Set	03-5100-7	FDA UDI	Class II	Active
GranuFlo	0FD3251-3B	FDA UDI	Class II	Active
NaturaLyte	08-3201-4	FDA UDI	Class II	Active
NaturaLyte	08-2351-8	FDA UDI	Class II	Active
NaturaLyte	13-2251-0	FDA UDI	Class II	Active
Citrasate Dry	0FD2251-DA	FDA UDI	Class II	Active
NaturaLyte	08-1231-3	FDA UDI	Class II	Active
Acid connector guide 1 Gal	F50044953	FDA UDI	Class II	Active
Bicarby	RFP-400-G	FDA UDI	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.