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  "name": "Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040",
  "description": "FDA recall Z-1878-2023 — TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040 (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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1878-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1878-2023: TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040",
      "text": "The FDA logged enforcement record Z-1878-2023: TELEFLEX LLC is voluntarily recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040 — 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 14026704341167, Batch Numbers:  18FT35, 18GG16, 18GG19, 18GG23, 18GG34, 18GT32, 18HG17, 18HG21, 18HG22, 18HG29, 18HG30, 18IG15, 18JG01, 18JG03, 18JG16, 18JG19, 18JG35, 18JG37, 18KG17, 18KG19, 18KG38, 18LG12, 18LG14, 18LG18, 18LG30, 19AG01, 19AG19, 19AG29, 19BG18, 19BG32, 19BG33, 19CG01, 19CG02, 19CT26, 19CT33, 19CT53, 19CT73, 19CT80, 19CT82, 19DT05, 19DT30, 19DT35, 19DT38, 19DT42, 19ET18, 19ET34, 19ET39, 19ET40, 19ET58, 19ET60, 19ET61, 19ET65, 19ET69, 19FT01, 19FT41, 19GT13, 19GT16, 19GT63, 19HT31, 19HT82, 19IT01, 19IT14, 19JT35, 19JT56, 19JT63, 19KT02, 19KT41, 19KT46, 19LT21, 19LT36, 20AT22, 20AT53, 20BT01, 20BT02, 20CT05, 20DT23, 20DT29, 20DT32, 20DT35, 20ET04, 20ET33, 20ET34, 20ET38, 20ET39, 20FT17, 20FT19, 20FT60, 20FT64, 20FT68, 20GT11, 20GT34, KME20H1786, KME20H2999, KME20J0367, KME20J0494, KME20J1209, KME20J1388, KME20M2796, KME20M2906, KME20M2907, KME20M2994, KME20M3092, KME21A1005, KME21A1006, KME21A2030, KME21A2037, KME21A3023, KME21A3024, KME21A3028, KME21A3029, KME21B0259, KME21B0788, KME21B0994, KME21B1198, KME21B1286, KME21B1288, KME21B1620, KME21B2627, KME21B2628, KME21B2705, KME21C0428, KME21C1121, KME21C1199, KME21C1879, KME21C3336, KME21F0980, KME21K1094, KME21K1655, KME21K1714, KME21K1841, KME21K2300, KME21K3006, KME21L2290, KME21L2744, KME21L2745, KME21L2760, KME21L2761, KME21L2787, KME21L2869, KME21M0203, KME21M0801, KME21M0809, KME21M0950, KME21M1706, KME21M1904, KME21M1905, KME21M2908, KME22A0561, KME22A2283, KME22A2404, KME22A2849, KME22A2915, KME22A3199, KME22B0002, KME22B0003, KME22B0004, KME22B0043, KME22B0123, KME22B0124, KME22B0165, KME22B0192, KME22B0545, KME22B0585, KME22B1999, KME22C1877, KME22C1989, KME22C1990, KME22C2189, KME22C2479, KME22C2480, KME22C2481, KME22C2659, KME22C2660, KME22C2760, KME22C2839, KME22C2840, KME22C2866, KME22C2966, KME22C3124, KME22C3126, KME22C3454, KME22D0284, KME22D1566, KME22D1674, KME22D1698, KME22D1813, KME22D1890, KME22D2708, KME22D3011, KME22E0730, KME22E0731, KME22E0945, KME22E1105, KME22E1394, KME22E1499, KME22E1933, KME22E2376, KME22E2659, KME22E2810, KME22E2889, KME22F0001, KME22F0541, KME22F2997, KME22F3120, KME22F3243, KME22F3423, KME22G0815, KME22G1098, KME22G1167, KME22G1228, KME22G1229, KME22G1330, KME22G2240, KME22G2307, KME22G2576, KME22G2629, KME22G2924, KME22G3134, KME22H0545, KME22H0600, KME22H0761, KME22H1361, KME22H1725, KME22H1932, KME22H2056, KME22H2520, KME22H3068. A RECORDED FDA enforcement action (occurred=true).",
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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-1878-2023 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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      "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-1878-2023/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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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      "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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            "Field": "Initiated",
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