BEUDAMED
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    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code KDI·July 8, 2013

    Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·February 20, 2004

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc. dba Renal Solutions·Product code KDI·April 1, 2013

    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code KDI·October 29, 2015

    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·April 1, 2016

    2008T HD SYS. W/O CDX BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    2008T Hemodialysis System without CDX

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024

    Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·November 5, 2018

    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·May 31, 2019

    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·May 31, 2019

    Prismaflex System, Prismaflex Control Unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·February 6, 2020

    Prismaflex System, Prismaflex Control Unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·February 6, 2020

    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 YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020

    Fresenius 2008K@home Series : Hemodialysis System

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016

    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 24, 2018

    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.

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·April 3, 2019

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDI·September 29, 2021