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  "@type": "schema:Dataset",
  "name": "Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125",
  "description": "FDA recall Z-1838-2023 — TELEFLEX LLC is recalling Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125 (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1838-2023/enforcement-record",
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      "name": "FDA recall Z-1838-2023: TELEFLEX LLC is recalling Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125",
      "text": "The FDA logged enforcement record Z-1838-2023: TELEFLEX LLC is voluntarily recalling Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170125 — reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-25. Affected lots/codes: UDI/DI 14026704644886, Batch Numbers:  18JG11, 18JG26, 18JG34, 18KG18, 18KG23, 18LG15, 18LG22, 19AG09, 19AG21, 19AG24, 19AG37, 19BG04, 19BG07, 19BG12, 19BG16, 19BG21, 19CT41, 19CT49, 19CT55, 19DT38, 19ET45, 19ET77, 19FT24, 19GT59, 19HT35, 20CT51, 20DT37, 20ET16, 20ET28, 20GG41, 20GG45, KME20J0332, KME20K0948, KME20K2546, KME20L0629, KME20L0630, KME20L0631, KME20L1484, KME20L2399, KME20M0810, KME21A1887, KME21A1888, KME21B0577, KME21B1142, KME21C0490, KME21C3427, KME21C3428, KME21D1022, KME21K1724, KME21K1725, KME21K1726, KME21L1891, KME21L1892, KME21M0433, KME21M1817, KME22B0724, KME22B0929, KME22B1072, KME22C0912, KME22D0786, KME22D3646, KME22D3647, KME22E1131, KME22E1237, KME22E2262, KME22F2865, KME22F2867, KME22G0565, KME22G1099, KME22G1517, KME22H1628, KME22H1899. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-1838-2023&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-1838-2023&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."
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      "name": "FDA classified recall Z-1838-2023 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.",
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        "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-1838-2023&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-1838-2023/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.",
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      "reviewStatus": "current",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "TELEFLEX LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.",
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            "Field": "Initiated",
            "Value": "2023-05-25",
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            "Value": "UDI/DI 14026704644886, Batch Numbers:  18JG11, 18JG26, 18JG34, 18KG18, 18KG23, 18LG15, 18LG22, 19AG09, 19AG21, 19AG24, 19AG37, 19BG04, 19BG07, 19BG12, 19BG16, 19BG21, 19CT41, 19CT49, 19CT55, 19DT38, 19ET45, 19ET77, 19FT24, 19GT59, 19HT35, 20CT51, 20DT37, 20ET16, 20ET28, 20GG41, 20GG45, KME20J0332, KME20K0948, KME20K2546, KME20L0629, KME20L0630, KME20L0631, KME20L1484, KME20L2399, KME20M0810, KME21A1887, KME21A1888, KME21B0577, KME21B1142, KME21C0490, KME21C3427, KME21C3428, KME21D1022, KME21K1724, KME21K1725, KME21K1726, KME21L1891, KME21L1892, KME21M0433, KME21M1817, KME22B0724, KME22B0929, KME22B1072, KME22C0912, KME22D0786, KME22D3646, KME22D3647, KME22E1131, KME22E1237, KME22E2262, KME22F2865, KME22F2867, KME22G0565, KME22G1099, KME22G1517, KME22H1628, KME22H1899",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including Puerto Rico.",
            "Status": "recorded"
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