Fresenius Medical Care Renal Therapies Group, LLC recalls

27 recalls on record · latest: May 29, 2019

Official U.S. recall history for Fresenius Medical Care Renal Therapies Group, LLC, compiled from official government records.

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Fresenius Medical Care Renal Therapies Group, LLC recalls Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in con…

May 29, 2019 · Medical device recalls Moderate risk Additional Instructions: step-by step handling and inserting the cassette into…

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysi…

April 3, 2019 · Medical device recalls Power Logic Board Fail Message on the 2008T BlueStar Machine with software vers…

Fresenius Medical Care Renal Therapies Group, LLC recalls Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

November 5, 2018 · Medical device recalls Moderate risk Potential for external blood leaks from the dialyzer header

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

October 9, 2018 · Medical device recalls Discolored powder has confirmed the presence of a foreign substance

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

October 9, 2018 · Medical device recalls Discolored powder has confirmed the presence of a foreign substance

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis

October 9, 2018 · Medical device recalls Discolored powder has confirmed the presence of a foreign substance

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Nu…

July 13, 2018 · Medical device recalls Moderate risk In the hemodialysis machine during the cleaning/disinfection program, when ther…

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Num…

July 13, 2018 · Medical device recalls Moderate risk In the hemodialysis machine during the cleaning/disinfection program, when ther…

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis recalled over labeling errors

May 2, 2018 · Medical device recalls Moderate risk The bottles are mislabeled with an incorrect part number.

Fresenius Medical Care Renal Therapies Group, LLC recalls Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chr…

January 24, 2018 · Medical device recalls Moderate risk The recalling firm identified a software issue related to the Patient Line Chec…

DELFLEX Peritoneal Dialysis Solution recalled over sterility concerns

December 20, 2017 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solutio…

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840…

December 14, 2017 · Medical device recalls Moderate risk When the recirculation ultrafiltration (UF) Goal is set to a value greater than…

Fresenius Medical Care Renal Therapies Group product recalled over sterility concerns

November 13, 2017 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Medical Care Renal Therapies Group, LLC recalls 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

October 5, 2017 · Medical device recalls Moderate risk While reviewing documentation for the next software release of the 2008T, an R&…

Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter bottle This concentrate is formulated to be…

September 29, 2017 · Medical device recalls Moderate risk The label specifies the potassium concentration is 2.0 mEq/L. Some of the produ…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008K@home Series : Hemodialysis System

December 21, 2016 · Medical device recalls Moderate risk When the UF Rate, Goal or Time is adjusted using the up and down arrow keys…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008K2 Series : Hemodialysis System

December 21, 2016 · Medical device recalls Moderate risk When the UF Rate, Goal or Time is adjusted using the up and down arrow keys…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008T Series Hemodialysis System

December 21, 2016 · Medical device recalls Moderate risk When the UF Rate, Goal or Time is adjusted using the up and down arrow keys…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008K Series : Hemodialysis System

December 21, 2016 · Medical device recalls Moderate risk When the UF Rate, Goal or Time is adjusted using the up and down arrow keys…

Fresenius Medical Care Renal Therapies Group, LLC recalls Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit ox…

May 24, 2016 · Medical device recalls Moderate risk Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T He…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2…

March 10, 2016 · Medical device recalls Moderate risk Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Bloo…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

February 26, 2016 · Medical device recalls Moderate risk Dialyzer header leak due to possible improper torque

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate D…

January 18, 2016 · Medical device recalls Moderate risk On the label calcium (Ca) listed in the right upper corner of the label (red ba…

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

December 15, 2015 · Medical device recalls Moderate risk The door latch may not fully close and the door may open unexpectedly. The door…

Fresenius 132 Gallon Dry Acid Dissolution Unit recalled over fire hazard

October 23, 2015 · Medical device recalls Moderate risk Dissolution units and replacement motors units do not provide full thermal prot…

Fresenius Modified Mixer Motor recalled over fire hazard

October 23, 2015 · Medical device recalls Moderate risk Dissolution units and replacement motors units do not provide full thermal prot…

Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047 recalled over fire hazard

October 23, 2015 · Medical device recalls Moderate risk Dissolution units and replacement motors units do not provide full thermal prot…