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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1864-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.",
  "description": "FDA recall Z-1864-2025 — NxStage Medical Inc is recalling NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1864-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.",
    "manufacturer": {
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      "name": "NxStage Medical Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1864-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1864-2025: NxStage Medical Inc is recalling NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.",
      "text": "The FDA logged enforcement record Z-1864-2025: NxStage Medical Inc is voluntarily recalling NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456. — reason: Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-28. Affected lots/codes: a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309.  b.  UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390.  c.  UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, Q2407214.  d.  UDI-DI number: M535RFP4030. Device Catalog Number RFP-403. Lot Number: Q2407311.  e.  UDI-DI number: M535RFP4040. Device Catalog Number RFP-404. Lot Numbers: Q2407062, Q2407063, Q2407064, Q2407065, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407301, Q2407302, Q2407303, Q2407304, Q2407305, Q2407306, Q2407391, Q2407392, Q2407405, Q2407406.  f.  UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312.  g.  UDI-DI number: M535RFP4530. Device Catalog Number RFP-453. Lot Number: Q2407066.  h.  UDI-DI number: M535RFP4540. Device Catalog Number RFP-454. Lot Numbers: Q2407145, Q2407146, Q2407226.  j. UDI-DI number: M535RFP4560. Device Catalog Number RFP-456. Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "occurred": true,
        "supported": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1864-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1864-2025&lang=eng"
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1864-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1864-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1864-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1864-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1864-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
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      "name": "FDA recall details — Z-1864-2025",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1864-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "NxStage Medical Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-04-28",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a. UDI-DI number: M535RFP4000. Device Catalog Number RFP-400. Lot Numbers: Q2407307, Q2407308, Q2407309.  b.  UDI-DI number: M535RFP4010. Device Catalog Number RFP-401. Lot Numbers: Q2407061, Q2407147, Q2407148, Q2407149, Q2407313, Q2407386, Q2407387, Q2407388, Q2407389, Q2407390.  c.  UDI-DI number: M535RFP4020. Device Catalog Number RFP-402. Lot Numbers: Q2407213, Q2407214.  d.  UDI-DI number: M535RFP4030. Device Catalog Number RFP-403. Lot Number: Q2407311.  e.  UDI-DI number: M535RFP4040. Device Catalog Number RFP-404. Lot Numbers: Q2407062, Q2407063, Q2407064, Q2407065, Q2407067, Q2407068, Q2407069, Q2407070, Q2407071, Q2407217, Q2407218, Q2407219, Q2407220, Q2407221, Q2407222, Q2407223, Q2407224, Q2407225, Q2407301, Q2407302, Q2407303, Q2407304, Q2407305, Q2407306, Q2407391, Q2407392, Q2407405, Q2407406.  f.  UDI-DI number: M535RFP4060. Device Catalog Number RFP-406. Lot Numbers: Q2407072, Q2407137, Q2407140, Q2407141, Q2407216, Q2407310, Q2407312.  g.  UDI-DI number: M535RFP4530. Device Catalog Number RFP-453. Lot Number: Q2407066.  h.  UDI-DI number: M535RFP4540. Device Catalog Number RFP-454. Lot Numbers: Q2407145, Q2407146, Q2407226.  j. UDI-DI number: M535RFP4560. Device Catalog Number RFP-456. Lot Numbers: Q2407138, Q2407139, Q2407142, Q2407143, Q2407144, Q2407227.",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
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}