Food, drugs, devices › NxStage Medical, Inc.
Device recall: NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
NxStage Medical, Inc. (Lawrence, MA) initiated this device recall on 10 Nov 2017; FDA lists 1 product record under event 79276, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Dec 2019. Initiation: voluntary: firm initiated. NxStage Medical, Inc. has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
NxStage Medical, Inc., Lawrence, MA.
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."
Distribution
"US nationwide distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1132-2018 | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One | 1243400 units | Class II | Terminated | 28 Mar 2018 |
Context
Other enforcement events for NxStage Medical, Inc.
All 13 events for NxStage Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Dec 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.