BEUDAMED
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    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 4, 2014

    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 Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and chronic dialysis therapy

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·March 10, 2016

    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 4, 2017

    Prismaflex 5.10 US, Product Code 113081 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

    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

    FDA Recall
    Terminated ·B Braun Medical Inc·Product code KDI·January 28, 2022

    Prismaflex Control Unit

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·April 7, 2020

    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 4, 2014

    Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 4, 2014

    Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 4, 2014

    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·April 16, 2014

    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box

    FDA Recall
    Terminated ·Gambro Renal Products, Incorporated·Product code KDI·July 18, 2014

    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K System w/ Short Cabinet; 190305 2008K System w/o Diasafe; 190301 2008K System w/o HP; 190372 2008K System w/o HP; 190303 2008K System w/o OLC and Diasafe; 190304 2008K System w/o OLC and Diasafe and HP; 190452 2008K System w/o OLC and w/ Diasafe Plus; 190303 2008K W/O OLC and DIASAFE W/ HEPARIN PUMP; 190304 2008K W/O OLC and DIASAFE W/O HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KDI·February 20, 2015

    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code KDI·August 18, 2015

    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.

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

    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 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