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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1128-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442",
  "description": "FDA recall Z-1128-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442 (Devices, Class I). 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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      "name": "U.S. Food & Drug Administration"
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1128-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1128-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442",
      "text": "The FDA logged enforcement record Z-1128-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits, trays, and packs labeled as follows:    a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470;   b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471;   c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442;   d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472;   e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474;   f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476;   g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478;   h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442 — reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: a) REF DYND41470, UDI/DI 40080196033608(case), 10080196033607(unit), Lot Numbers:  2022042690, 2022070690, 2022090790, 2022102590, 2023051790;   b) REF DYND41471, UDI/DI 40080196033622(case), 10080196033621(unit), Lot Numbers:  2022070190, 2022072890, 2022101090, 2022121390, 2022121990, 2023022890, 2023051890;   c) REF DYND40442, UDI/DI 40080196032618(case), 10080196032617(unit), Lot Numbers: 2022040590, 2022051890, 2022072290, 2022090690, 2022100790, 2022093090, 2022101190, 2022122890, 2023051290, 2023060590, 2023080290, 2023092690;   d) REF DYND41472, UDI/DI 40080196996538(case), 10080196996537(unit), Lot Numbers: 2022042590, 2022062390, 2022070590, 2022072590, 2022080890, 2022082590, 2023010690, 2023022790, 2023030890, 2023041090, 2023041990, 2023070590;    e) REF DYND41474, UDI/DI 40080196033653(case), 10080196033652(unit), Lot Numbers: 2022082390, 2022101090, 2022121290, 2022122090, 2023030390, 2023070590, 2023092590;    f) REF DYND41476, UDI/DI 40080196033660(case), 10080196033669(unit), Lot Numbers:  2022062290, 2022072890, 2022102490, 2022122090, 2023030190, 2023051990;   g) REF DYND41478, UDI/DI 40080196033677(case), 10080196033676(unit), Lot Numbers:  2022042890, 2022070690, 2022082390, 2022100690, 2022121290, 2023010490, 2023041490, 2023080890, 2023092590;   h) REF DYND41442, UDI/DI 40080196033578(case), 10080196033577(unit), Lot Numbers:   2022031590, 2022032290, 2022042790, 2022060290, 2022053190, 2022052790, 2022060690, 2022072690, 2022072790, 2022082490, 2022102490, 2023012490, 2023030390, 2023032390, 2023032490, 2023041790, 2023060190, 2023060290, 2023070590. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1128-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-1128-2024&lang=eng"
        }
      },
      "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-1128-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1128-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-1128-2024&lang=eng",
        "value": "Class I",
        "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-1128-2024&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-1128-2024/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
      },
      "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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-1128-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1128-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-15",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYND41470, UDI/DI 40080196033608(case), 10080196033607(unit), Lot Numbers:  2022042690, 2022070690, 2022090790, 2022102590, 2023051790;   b) REF DYND41471, UDI/DI 40080196033622(case), 10080196033621(unit), Lot Numbers:  2022070190, 2022072890, 2022101090, 2022121390, 2022121990, 2023022890, 2023051890;   c) REF DYND40442, UDI/DI 40080196032618(case), 10080196032617(unit), Lot Numbers: 2022040590, 2022051890, 2022072290, 2022090690, 2022100790, 2022093090, 2022101190, 2022122890, 2023051290, 2023060590, 2023080290, 2023092690;   d) REF DYND41472, UDI/DI 40080196996538(case), 10080196996537(unit), Lot Numbers: 2022042590, 2022062390, 2022070590, 2022072590, 2022080890, 2022082590, 2023010690, 2023022790, 2023030890, 2023041090, 2023041990, 2023070590;    e) REF DYND41474, UDI/DI 40080196033653(case), 10080196033652(unit), Lot Numbers: 2022082390, 2022101090, 2022121290, 2022122090, 2023030390, 2023070590, 2023092590;    f) REF DYND41476, UDI/DI 40080196033660(case), 10080196033669(unit), Lot Numbers:  2022062290, 2022072890, 2022102490, 2022122090, 2023030190, 2023051990;   g) REF DYND41478, UDI/DI 40080196033677(case), 10080196033676(unit), Lot Numbers:  2022042890, 2022070690, 2022082390, 2022100690, 2022121290, 2023010490, 2023041490, 2023080890, 2023092590;   h) REF DYND41442, UDI/DI 40080196033578(case), 10080196033577(unit), Lot Numbers:   2022031590, 2022032290, 2022042790, 2022060290, 2022053190, 2022052790, 2022060690, 2022072690, 2022072790, 2022082490, 2022102490, 2023012490, 2023030390, 2023032390, 2023032490, 2023041790, 2023060190, 2023060290, 2023070590",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}