Home / Recalls / NxStage Medical, Inc. / Z-0326-2016

Z-0326-2016 Class II Terminated

Recalled by NxStage Medical, Inc. — Lawrence, MA

Recall Details

Product Type
Devices
Report Date
December 2, 2015
Initiation Date
October 29, 2015
Termination Date
April 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
323 units

Product Description

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

Reason for Recall

Ultrafiltration (UF) Volume software error inaccurate fluid removal

Distribution Pattern

Worldwide Distribution. US Nationwide, Netherlands, and Sweden.

Code Information

Software versions 4.9 and 4.10

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  • Z-0697-2020 Class II — Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) (August 27, 2019)
  • Z-1706-2019 Class II — NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlo (April 11, 2019)
  • Z-1707-2019 Class II — NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solu (April 11, 2019)
  • Z-0501-2019 Class II — NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxS (October 17, 2018)
  • Z-0502-2019 Class II — NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxS (October 17, 2018)
  • Z-0505-2019 Class II — NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxS (October 17, 2018)
  • Z-0503-2019 Class II — NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis N (October 17, 2018)
  • Z-0507-2019 Class II — NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis (October 17, 2018)