Data / Medical devices / United States / Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC: FDA-registered device maker in Waltham, MA, United States, 59 510(k) clearances
Fresenius Medical Care Renal Therapies Group, LLC is registered with the FDA (registration 1225714) in Waltham, MA, United States. It lists 13 device types. The FDA files 59 510(k) clearances under its listings, the newest dated January 29, 2026. 95 recall events name it as the recalling firm (5 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1225714
- FEI number
- 3001451489
- Address
- 920 Winter Street, Waltham, MA, United States, 02451
- Owner or operator
- Fresenius Medical Care Renal Therapies Group, LLC (9030510)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 8, 2008
- Registered through
- 2026
- Brand names listed
- 2008K Hemodialysis Machine, 2008K2 Hemodialysis Machine, 2008K@HOME HEMODIALYSIS MACHINE, 2008K@Home HD Machine w/WWD (WETALERT), 2008K@home Hemodialysis Machine, 2008T BlueStar Hemodialysis Machine, 2008T Hemodialysis Machine, 4 LEAD ECO PREFILLED W/SNAP DISCONNECT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Autonomous Extracorporeal Blood Leak Detector/Alarm | ODX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dialyzer, Capillary, Hollow Fiber | FJI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Disinfectant, Dialysate Delivery System | NII | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hemodialysis System For Home Use | ONW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Transducer, Dialysis | FIB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Dialysate Delivery, Semi-Automatic, Peritoneal | KPF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 29, 2026 | K253462 | NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| November 14, 2025 | K250471 | AquaC UNO H | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 9, 2025 | K252181 | AquaA | FIP | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| September 9, 2025 | K252180 | Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| June 13, 2025 | K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 30, 2025 | K243505 | 5008X Hemodialysis System | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 4, 2025 | K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 3, 2025 | K250404 | 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 | KDJ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| June 13, 2024 | K232953 | AquaBplus; AquaB LITE | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| December 6, 2023 | K231125 | 2008T BlueStar Hemodialysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 31, 2023 | K213992 | CombiSet Hemodialysis Blood Tubing Set | FJK | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| October 31, 2022 | K222318 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| October 27, 2022 | K222952 | 2008T BlueStar Hemodailysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| July 27, 2022 | K213507 | AquaA | FIP | Substantially Equivalent | Fresenius Medical Care Rental Therapies Group, LLC | accessdata.fda.gov |
| May 12, 2022 | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 21, 2020 | K192707 | Optiflux F180NR Dialyzer | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 18, 2020 | 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 | KOC | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 8, 2020 | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 24, 2020 | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 24, 2020 | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| August 23, 2019 | K190459 | Hemoflow F3 and F4 Dialyzers | FJI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 24, 2018 | K181108 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 21, 2018 | 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 | KDJ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 10, 2018 | K173972 | 2008T BlueStar Hemodialysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 1, 2018 | K173718 | Liberty Cycler Set | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 14, 2018 | K173651 | Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set | KDJ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| January 24, 2018 | K173363 | Cycler Drain Bag Set | KDJ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| September 15, 2017 | K171652 | Fresenius Liberty Select Cycler | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 18, 2017 | K162716 | bibag | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| April 6, 2017 | K162488 | Optiflux dialyzer | KDI | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| April 26, 2016 | K153449 | 2008K2 Hemodialysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| December 10, 2015 | K150708 | 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| November 5, 2015 | K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER | KOC | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| October 19, 2015 | K143617 | AquaC UNO H | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
| April 1, 2015 | K141997 | CRIT-LINE IV SYSTEM | KOC | Substantially Equivalent | Fresenius Medical Care | accessdata.fda.gov |
| July 30, 2014 | K141145 | LIBERTY PDX CYCLER | FKX | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| July 7, 2014 | K133299 | ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY | KDI | Substantially Equivalent | Fresenius Medical Care, North America - Renal Ther | accessdata.fda.gov |
| April 22, 2014 | K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
| September 19, 2013 | K124024 | APD LUER-LOCK ADAPTER | KDJ | Substantially Equivalent | Fresensius Medical Care North America | accessdata.fda.gov |
| September 9, 2013 | K123630 | FRESENIUS LIBERTY CYCLER | FKX | Substantially Equivalent | Fresenius Medical Care North America, Design Cente | accessdata.fda.gov |
| August 29, 2013 | K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS | KPO | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| January 17, 2013 | K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) | ONW | Substantially Equivalent | Fresenius Medical Care North America, Design Cente | accessdata.fda.gov |
| June 15, 2012 | K120823 | BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS | FJK | Substantially Equivalent | Fresenius Medical Care North America, Design Cente | accessdata.fda.gov |
| February 3, 2011 | K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | ONW | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| December 29, 2008 | K083542 | FRESENIUS STERILE STAY SAFE CAP | KDJ | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| March 31, 2005 | K043363 | FRESENIUS LIBERTY CYCLER | FKX | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| October 30, 2002 | K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR | KOC | Substantially Equivalent | Fresenius Medical Care | accessdata.fda.gov |
| April 27, 2001 | K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 | KOC | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| December 1, 2000 | K003445 | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | FIB | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| July 28, 2000 | K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 | FJK | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| June 23, 2000 | K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) | FJK | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| May 9, 2000 | K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 | FJK | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
| November 1, 1996 | K962081 | COMBILINES HEMODIALYSIS BLOOD TUBING SET | FJK | Substantially Equivalent | National Medical Care, Medical Products Div., Inc. | accessdata.fda.gov |
| July 31, 1996 | K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | KPF | Substantially Equivalent | Fresenius USA, Inc. | accessdata.fda.gov |
| July 17, 1991 | K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING | KPO | Substantially Equivalent | Fresenius USA, Inc. | accessdata.fda.gov |
| February 26, 1990 | K896764 | UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 | KDJ | Substantially Equivalent | National Medical Care, Medical Products Div., Inc. | accessdata.fda.gov |
| October 13, 1982 | K822550 | SAFE LOCK TITANIUM ADAPTER SET | FKX | Substantially Equivalent | American Medical Products, Inc. | accessdata.fda.gov |
| October 13, 1982 | K822546 | SAFE LOCK SEALING CAPS | FKX | Substantially Equivalent | American Medical Products, Inc. | accessdata.fda.gov |
| August 31, 1981 | K811986 | THE AMP 80/2 PEDIATRIC CYCLER SYSTEM | FKX | Substantially Equivalent | American Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 10, 2026 | 99556 | Class II | Ongoing | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia. | accessdata.fda.gov |
| July 29, 2026 | 99700 | Class II | Ongoing | CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1 | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. | accessdata.fda.gov |
| July 14, 2026 | 99543 | Class II | Ongoing | GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis | Complaints of blue-green discoloration in product | accessdata.fda.gov |
| June 30, 2026 | 99438 | Class II | Ongoing | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130. | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines. | accessdata.fda.gov |
| May 12, 2026 | 98877 | Class II | Ongoing | Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G | Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated | accessdata.fda.gov |
| May 11, 2026 | 99061 | Class II | Ongoing | 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Num | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. | accessdata.fda.gov |
| May 7, 2026 | 98892 | Class II | Ongoing | Bicarby Dialysate; Model number: RFP-400-G | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium | accessdata.fda.gov |
| October 25, 2025 | 97934 | Class II | Ongoing | 5008X CAREsystem +CLiC +CDX | Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled. | accessdata.fda.gov |
| August 29, 2025 | 97543 | Class II | Ongoing | Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F | To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap. | accessdata.fda.gov |
| April 29, 2025 | 96827 | Class II | Ongoing | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X | Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration. | accessdata.fda.gov |
| December 5, 2024 | 95884 | Class II | Ongoing | Dialyzer Optiflux 160NRe | Potential for internal blood leaks due to cracked polyurethane | accessdata.fda.gov |
| August 8, 2024 | 95169 | Class II | Ongoing | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124 | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff. | accessdata.fda.gov |
| June 3, 2024 | 94775 | Class II | Ongoing | 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | accessdata.fda.gov |
| May 16, 2024 | 94676 | Class II | Ongoing | US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1 | Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply. | accessdata.fda.gov |
| April 17, 2024 | 94463 | Class II | Ongoing | Blood Pump Rotor, Model Number: F40015481 Rev A | An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. | accessdata.fda.gov |
| April 8, 2024 | 94393 | Class II | Ongoing | Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchan | Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system. | accessdata.fda.gov |
| January 23, 2024 | 94084 | Class I | Ongoing | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | accessdata.fda.gov |
| October 24, 2023 | 93579 | Class III | Ongoing | Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. | accessdata.fda.gov |
| October 10, 2023 | 93396 | Class II | Ongoing | Stay Safe Cap | Updating the labeling to include additional warnings and contraindications for potential side effects. | accessdata.fda.gov |
| September 6, 2023 | 92788 | Class I | Ongoing | 2008T Hemodialysis SYS, with CDX | Potential PCBA leaching from tubing of hemodialysis machines. | accessdata.fda.gov |
| August 8, 2023 | 92906 | Class I | Ongoing | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case | There is a potential for blood backfill leakage and foreign material. | accessdata.fda.gov |
| October 4, 2022 | 90947 | Class II | Ongoing | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. | The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free. | accessdata.fda.gov |
| July 27, 2022 | 91154 | Class II | Ongoing | 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM | (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device". | accessdata.fda.gov |
| June 21, 2022 | 90757 | Class II | Ongoing | AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US | Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured | accessdata.fda.gov |
| June 16, 2022 | 90527 | Class II | Ongoing | AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US | Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is t | accessdata.fda.gov |
| June 1, 2022 | 90419 | Class II | Terminated | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection. | accessdata.fda.gov |
| May 31, 2022 | 90438 | Class II | Ongoing | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0 | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | accessdata.fda.gov |
| May 4, 2022 | 90367 | Class II | Terminated | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. | accessdata.fda.gov |
| December 7, 2021 | 89369 | Class II | Ongoing | Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas | Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection. | accessdata.fda.gov |
| August 3, 2021 | 90411 | Class II | Terminated | AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US) | AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation | accessdata.fda.gov |
| April 28, 2021 | 87998 | Class II | Terminated | (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALY | Exposed to freezing temperatures due to refrigerated truck malfunctions | accessdata.fda.gov |
| March 18, 2021 | 87659 | Class II | Terminated | AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation | accessdata.fda.gov |
| December 17, 2020 | 87006 | Class II | Terminated | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9 | Bottles Missing Product Label | accessdata.fda.gov |
| November 23, 2020 | 86939 | Class II | Ongoing | Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia | The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification. | accessdata.fda.gov |
| November 7, 2020 | 86855 | Class II | Ongoing | NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificia | The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. | accessdata.fda.gov |
| September 12, 2020 | 86537 | Class II | Completed | Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 | The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may le | accessdata.fda.gov |
| September 1, 2020 | 86410 | Class II | Terminated | AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Aq | Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff. | accessdata.fda.gov |
| March 12, 2020 | 85310 | Class II | Ongoing | Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL | A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine | accessdata.fda.gov |
| January 29, 2020 | 84945 | Class II | Terminated | Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home | The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part. | accessdata.fda.gov |
| May 29, 2019 | 83164 | Class II | Terminated | 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 (D | 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. | accessdata.fda.gov |
| April 3, 2019 | 82729 | Class III | Terminated | 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. | Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72. | accessdata.fda.gov |
| November 5, 2018 | 81598 | Class II | Terminated | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E | Potential for external blood leaks from the dialyzer header | accessdata.fda.gov |
| October 9, 2018 | 81451 | Class III | Terminated | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis | Discolored powder has confirmed the presence of a foreign substance | accessdata.fda.gov |
| July 13, 2018 | 80875 | Class II | Terminated | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. | 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 e | accessdata.fda.gov |
| May 2, 2018 | 80101 | Class II | Terminated | NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonat | The bottles are mislabeled with an incorrect part number. | accessdata.fda.gov |
| January 24, 2018 | 79625 | Class II | Terminated | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. | 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. | accessdata.fda.gov |
| December 14, 2017 | 79478 | Class II | Terminated | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Numb | 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 th | accessdata.fda.gov |
| October 5, 2017 | 79239 | Class II | Terminated | 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. | 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 contai | accessdata.fda.gov |
| September 29, 2017 | 79236 | Class II | Terminated | NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible | 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. | accessdata.fda.gov |
| December 21, 2016 | 76037 | Class II | Terminated | Fresenius 2008T Series Hemodialysis System | 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 | accessdata.fda.gov |
| May 24, 2016 | 74241 | Class II | Terminated | Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in | 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. | accessdata.fda.gov |
| March 10, 2016 | 73487 | Class II | Terminated | Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hem | 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) | accessdata.fda.gov |
| February 26, 2016 | 73387 | Class II | Terminated | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis | Dialyzer header leak due to possible improper torque | accessdata.fda.gov |
| January 18, 2016 | 73077 | Class II | Terminated | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis | 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. | accessdata.fda.gov |
| December 15, 2015 | 72926 | Class II | Terminated | Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 | 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). | accessdata.fda.gov |
| October 23, 2015 | 72484 | Class II | Terminated | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis. | 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. | accessdata.fda.gov |
| July 16, 2015 | 71724 | Class II | Ongoing | Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB | Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. | accessdata.fda.gov |
| May 20, 2015 | 71160 | Class II | Ongoing | NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine wh | Bacterial contamination. | accessdata.fda.gov |
| April 27, 2015 | 71093 | Class II | Terminated | CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021 | Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber | accessdata.fda.gov |
| February 20, 2015 | 70574 | Class II | Terminated | 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2 | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. | accessdata.fda.gov |
| December 19, 2014 | 70288 | Class II | Terminated | Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemo | Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope | accessdata.fda.gov |
| December 16, 2014 | 70027 | Class II | Terminated | ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Deliver | Unqualified power assemblies shipped to customers. | accessdata.fda.gov |
| June 23, 2014 | 69158 | Class II | Terminated | Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. | Product was held at temperature above the labeled recommended storage temperature | accessdata.fda.gov |
| June 23, 2014 | 68585 | Class II | Terminated | BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in | Products were held at improper storage temperature | accessdata.fda.gov |
| May 1, 2014 | 68135 | Class III | Terminated | NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrat | Container cap may contain foreign material- 0.60% - 0.80% Manganese | accessdata.fda.gov |
| April 25, 2014 | 68042 | Class II | Terminated | Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 19 | 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump | accessdata.fda.gov |
| April 10, 2014 | 67922 | Class I | Ongoing | Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrat | Naturalyte Liquid Bicarbonate maybe contaminated | accessdata.fda.gov |
| February 4, 2014 | 67313 | Class II | Terminated | Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment. | Dialysate Port Leak During Priming of the Dialyzers | accessdata.fda.gov |
| December 17, 2013 | 66953 | Class II | Terminated | Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. | Bicarbonate Jug Adapter distributed prior to 510(k) approval | accessdata.fda.gov |
| November 12, 2013 | 66622 | Class II | Terminated | Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with | 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup | accessdata.fda.gov |
| October 14, 2013 | 66339 | Class II | Terminated | Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. | Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis | accessdata.fda.gov |
| August 29, 2013 | 65739 | Class II | Terminated | 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and hi | Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss | accessdata.fda.gov |
| June 3, 2013 | 65332 | Class II | Terminated | Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. | Cassette may leak during set up or during peritoneal dialysis treatment | accessdata.fda.gov |
| May 24, 2013 | 65090 | Class II | Terminated | Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T | Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber) | accessdata.fda.gov |
| November 26, 2012 | 63768 | Class III | Terminated | Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the h | GranuFlo Dry Acid Concentrate may show discoloration | accessdata.fda.gov |
| October 12, 2012 | 64175 | Class II | Terminated | Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis. | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. | accessdata.fda.gov |
| March 30, 2012 | 60865 | Not yet classified | Terminated | Fresenius Liberty Cycler Software, User Manuals, and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8. The Fresenius Liberty Cycler is intended for acute or chronic peritoneal di | Increased risk of intraperitoneal volume (IIPV), referred to as Overfill | accessdata.fda.gov |
| March 29, 2012 | 62108 | Class I | Terminated | Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,0 | Risk of Alkalosis with acetate containing dialysis acid concentrates | accessdata.fda.gov |
| March 16, 2012 | 61418 | Not yet classified | Terminated | Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x, 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machi | Sodium content does not meet product requirements | accessdata.fda.gov |
| March 6, 2012 | 61293 | Not yet classified | Terminated | Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. | Risk of internal blood leaks affecting the hemodialyzers. | accessdata.fda.gov |
| December 27, 2011 | 60734 | Not yet classified | Terminated | Fresenius Optiflux F250NRe Hemodialyzer,, intended for single use in acute and chronic hemodialysis Catalog No. 0500325E The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with acute or chronic renal | Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak | accessdata.fda.gov |
| August 11, 2011 | 59664 | Not yet classified | Terminated | CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste product | Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions | accessdata.fda.gov |
| May 4, 2011 | 59483 | Not yet classified | Terminated | Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a t | Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k) | accessdata.fda.gov |
| March 23, 2011 | 58736 | Not yet classified | Terminated | Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bic | Mislabeled: incorrect lot number printed on case labels | accessdata.fda.gov |
| February 16, 2011 | 57947 | Not yet classified | Terminated | Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overlo | There is an increased risk of an internal blood leak. | accessdata.fda.gov |
| January 19, 2011 | 57851 | Not yet classified | Terminated | Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fre | Cursor on the dialysis screen may disappear and not respond to user input | accessdata.fda.gov |
| November 19, 2010 | 57293 | Not yet classified | Terminated | Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9 | Hemodialysis Blood tubing Sets may develop kinking of the arterial line. | accessdata.fda.gov |
| September 3, 2010 | 56675 | Not yet classified | Terminated | LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexi | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. | accessdata.fda.gov |
| May 14, 2010 | 55771 | Not yet classified | Terminated | Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. Designed for single use acute and chronic hemodialysis. | Hemodialyzer may leak at the header/end cap | accessdata.fda.gov |
| November 20, 2009 | 54546 | Not yet classified | Terminated | Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. | accessdata.fda.gov |
| November 25, 2008 | 50491 | Not yet classified | Terminated | CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-s | Port may crack and separate resulting in potential blood exposure/blood loss for the patient | accessdata.fda.gov |
| December 3, 2007 | 46292 | Not yet classified | Terminated | Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) | Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss. | accessdata.fda.gov |
| March 22, 2006 | 35184 | Not yet classified | Terminated | Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028 | Stay safe trigger body may not connect to the extension set and result in associated peritonitis | accessdata.fda.gov |
| November 28, 2005 | 34165 | Not yet classified | Terminated | Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N | Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR | accessdata.fda.gov |
| September 20, 2004 | 30007 | Not yet classified | Terminated | Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034 | Peritoneal Dialysis Transfer Set may have occluded pathway | accessdata.fda.gov |
Compare with other makers
- All makers of System, Peritoneal, Automatic Delivery
- All makers of Accessories, Blood Circuit, Hemodialysis
- All makers of Subsystem, Water Purification
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Autonomous Extracorporeal Blood Leak Detector/Alarm
- All makers of Hemodialysis System For Home Use
Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.