Fresenius Medical Care Renal Therapies Group, LLC
20 recalls on record · Latest: Jun 12, 2019
FDA Devices Low Jun 12, 2019
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for a…
FDA Devices Moderate Dec 26, 2018
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
FDA Devices Low Dec 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Devices Low Dec 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Devices Low Dec 5, 2018
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Devices Moderate Sep 26, 2018
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …
FDA Devices Moderate Sep 26, 2018
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: …
FDA Devices Moderate Jun 13, 2018
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated t…
FDA Drug Moderate May 30, 2018
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
FDA Devices Moderate Apr 11, 2018
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2…
FDA Drug Moderate Mar 28, 2018
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 49230-209-23), R…
FDA Devices Moderate Jan 25, 2017
Fresenius 2008K@home Series : Hemodialysis System
FDA Devices Moderate Jan 25, 2017
Fresenius 2008K2 Series : Hemodialysis System
FDA Devices Moderate Jan 25, 2017
Fresenius 2008T Series Hemodialysis System
FDA Devices Moderate Jun 29, 2016
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 c…
FDA Devices Moderate Apr 13, 2016
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery Sy…
FDA Devices Moderate Feb 3, 2016
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
FDA Devices Moderate Nov 25, 2015
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
FDA Devices Moderate Nov 25, 2015
Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis.
FDA Devices Moderate Nov 25, 2015