Home / Recalls / NxStage Medical, Inc. / Z-0336-2016

Z-0336-2016 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
November 19, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
133 units

Product Description

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

Reason for Recall

Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed

Distribution Pattern

Worldwide Distribution.

Code Information

Software version 4.9 and 4.10

Other recalls by NxStage Medical, Inc.

  • Z-1864-2025 Class II — NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403 (April 28, 2025)
  • Z-2160-2024 Class II — NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog (May 14, 2024)
  • 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)