BEUDAMED
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    SYSTEM ONE WITH PUREFLOW SL

    FDA Adverse Event
    Death ·NXSTAGE·Product code FKR·May 15, 2014

    FRESENIUS NXSTAGE CONTROL UNIT NX2000-1

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code FKR·May 11, 2022

    FRESENIUS NXSTAGE CONTROL UNIT NX2000-1

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code FKR·May 11, 2022

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·December 19, 2025

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code FKR·December 4, 2025

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·September 3, 2025

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·May 3, 2019

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·April 3, 2023

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code FKR·September 20, 2022

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·May 5, 2023

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Death ·NXSTAGE MEDICAL, INC.·Product code FKR·March 3, 2017

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·April 27, 2017

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·February 22, 2018

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·February 20, 2018

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Malfunction ·NXSTAGE MEDICAL, INC.·Product code FKR·January 10, 2025

    PUREFLOW DIALYSATE CONCENTRATE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·August 16, 2019

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code FKR·August 29, 2019

    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code FKR·January 29, 2018

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code FKR·May 14, 2014

    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.

    FDA Recall
    Terminated ·NxStage Medical, Inc.·Product code FKR·May 14, 2014