NxStage Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1707-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Product Classification:

Class II

Date Initiated: April 11, 2019

Date Posted: June 12, 2019

Recall Number: Z-1707-2019

Event ID: 82693

Reason for Recall:

Certain lots were mislabeled with incorrect product number.

Status: Terminated

Product Quantity: 3,940 units

Code Information:

Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020

Distribution Pattern:

US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

Voluntary or Mandated:

Voluntary: Firm initiated