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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1118-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits, trays, and packs labeled as follows:    a) ER LACERATION TRAY - SNAG FREE, REF SUT12825;   b) LACERATION TRAY, REF SUT21580;   c) LACERATION TRAY, REF DYNDL1484B;",
  "description": "FDA recall Z-1118-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) ER LACERATION TRAY - SNAG FREE, REF SUT12825;   b) LACERATION TRAY, REF SUT21580;   c) LACERATION TRAY, REF DYNDL1484B; (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "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-1118-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits, trays, and packs labeled as follows:    a) ER LACERATION TRAY - SNAG FREE, REF SUT12825;   b) LACERATION TRAY, REF SUT21580;   c) LACERATION TRAY, REF DYNDL1484B;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1118-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1118-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) ER LACERATION TRAY - SNAG FREE, REF SUT12825;   b) LACERATION TRAY, REF SUT21580;   c) LACERATION TRAY, REF DYNDL1484B;",
      "text": "The FDA logged enforcement record Z-1118-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits, trays, and packs labeled as follows:    a) ER LACERATION TRAY - SNAG FREE, REF SUT12825;   b) LACERATION TRAY, REF SUT21580;   c) LACERATION TRAY, REF DYNDL1484B; — 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 SUT12825, UDI/DI 00653160356199 (case), 10653160356196 (unit), Lot Numbers:  23CBX773, 23EBB756, 23HBC776;   b) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers:  22EBC554, 22EBK107, 22EBR701, 22GBW369, 22JBI962, 22KBA966, 23DBD424, 23FBK832, 23GBR277, 23HBX352,;   c) REF DYNDL1484B, UDI/DI 20193489198741 (case), 10193489198744 (unit), Lot Numbers:  22HLB333, 22ILA328, 22KLA754, 22LLA450, 23ALA763, 23BLA321, 23BLA885, 23CLA874, 23FLA147, 23FLB061, 23HLA382. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1118-2024&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-1118-2024&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-1118-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1118-2024 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
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      "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-1118-2024&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-1118-2024&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-1118-2024/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-1118-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1118-2024",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
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          "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"
          }
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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          "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"
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        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-15",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF SUT12825, UDI/DI 00653160356199 (case), 10653160356196 (unit), Lot Numbers:  23CBX773, 23EBB756, 23HBC776;   b) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers:  22EBC554, 22EBK107, 22EBR701, 22GBW369, 22JBI962, 22KBA966, 23DBD424, 23FBK832, 23GBR277, 23HBX352,;   c) REF DYNDL1484B, UDI/DI 20193489198741 (case), 10193489198744 (unit), Lot Numbers:  22HLB333, 22ILA328, 22KLA754, 22LLA450, 23ALA763, 23BLA321, 23BLA885, 23CLA874, 23FLA147, 23FLB061, 23HLA382",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}