NxStage Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1132-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

Product Classification:

Class II

Date Initiated: November 10, 2017

Date Posted: March 28, 2018

Recall Number: Z-1132-2018

Event ID: 79276

Reason for Recall:

Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

Status: Terminated

Product Quantity: 1243400 units

Code Information:

RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560

Distribution Pattern:

US nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated