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Fresenius Medical Care Renal Therapies Group, Llc Recalls

20 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fresenius Medical Care Renal Therapies Group, Llc.

20Total Recalls
3Critical
311,571Units Affected
Apr 3, 2019Most Recent
All Recalls

Every Fresenius Medical Care Renal Therapies Group, Llc Recall

Sorted by most recent. Click any recall for full details.

20 recalls
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is ind...
Medical Devices·257 affected·Apr 3, 2019
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Medical Devices·9,097 affected·Nov 5, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Medical Devices·4,752 affected·Oct 9, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Medical Devices·92,225 affected·Oct 9, 2018
RecallFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
Medical Devices·22,320 affected·Oct 9, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Pro...
Medical Devices·40 affected·Jul 13, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Prod...
Medical Devices·80 affected·Jul 13, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is ...
Medical Devices·1,060 affected·May 2, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 4923...
Drugs·3,734 affected·Dec 20, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial...
Medical Devices·127 affected·Dec 14, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Injectable Drugs·25,356 affected·Nov 13, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K@home Series : Hemodialysis System
Medical Devices·1,400 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K2 Series : Hemodialysis System
Medical Devices·60,151 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008T Series Hemodialysis System
Medical Devices·65,361 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation a...
Respiratory Devices·875 affected·May 24, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate...
Medical Devices·8,384 affected·Mar 10, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Medical Devices·14,094 affected·Dec 15, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Medical Devices·348 affected·Oct 23, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemo...
Medical Devices·992 affected·Oct 23, 2015
CriticalFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Medical Devices·918 affected·Oct 23, 2015