FDA Devices recall · Reported March 28, 2018
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
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…
NxStage Medical, Inc. recalled NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One - a moderate-severity action.
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One was recalled by NxStage Medical, Inc. in March 28, 2018. Reason: Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause…. Check the official notice for the remedy. Verify recall #Z-1132-2018 with the FDA Devices before acting.
The recall
NxStage Medical, Inc. issued this moderate-severity FDA Devices recall-Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause….
- Moderate
- severity level
- 1.2M units
- affected scope
- Class II
- classification
- March 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1132-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope (see the Recall Profile below) places it in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1132-2018 |
| Date reported | March 28, 2018 |
| Date initiated | November 10, 2017 |
| Recalling firm | NxStage Medical, Inc. |
| Firm location | Lawrence, MA |
| Affected scope | 1243400 units |
| Distribution | US nationwide distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1132-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026