Devices

Device Recall NxStage

  • Model / Serial
    Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    NxStage Cartridge Express, CAR-170, for hemodialysis.
  • Manufacturer
    NxStage Medical, Inc.
  • 1 Event

Manufacturer

NxStage Medical, Inc.
  • Manufacturer Address
    NxStage Medical, Inc., 439 South Union Street, 5th Floor, Lawrence MA 01843-2800
  • Source
    USFDA

11 devices with a similar name

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Device Recall NXStage PureFlow SL SAK303
  • Model / Serial
    Lot 1117911, Exp. 2013-09
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx || The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
  • Manufacturer
    NxStage Medical, Inc.
Device Recall NxStage PureFlowB Solution
  • Model / Serial
    F023444
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
  • Product Description
    NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case || The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
  • Manufacturer
    NxStage Medical, Inc.
Device Recall NxStage PureFlowB Solution
  • Model / Serial
    Lot Number: F113662
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY, TX, ID, AR, CA and AL
  • Product Description
    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. || The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
  • Manufacturer
    NxStage Medical, Inc.
Device Recall NxStage Dialysate Sack (SAK) with Concentrate
  • Model / Serial
    Lot codes: 40279015 40179163 40179162 31279127 3067903 3057931 3057930 3047933 3047928
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Product Description
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-301 || Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, || Chloride 100, Glucose (mg/dL) 100 || Batch Size (liters) 60 || 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.
  • Manufacturer
    NxStage Medical, Inc.
Device Recall NxStage Dialysate Sack (SAK) with Concentrate
  • Model / Serial
    Lot codes: 40179127  40179107  40179109  40179105  40179093  40179034 31279120  31279118  3057921  3057920  3057915  3057914  3057906  3057905 3047924 3047923
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK.
  • Product Description
    NxStage Dialysate Sack (SAK) with Concentrate || for Use with PureFlow SL || REF: SAK-302 || Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100, || Batch Size (liters): 60 || 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.
  • Manufacturer
    NxStage Medical, Inc.
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