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  "name": "Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045",
  "description": "FDA recall Z-1879-2023 — TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045 (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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      "name": "FDA recall Z-1879-2023: TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045",
      "text": "The FDA logged enforcement record Z-1879-2023: TELEFLEX LLC is voluntarily recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045 — 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 14026704341174, Batch Numbers:  18FG33, 18GG16, 18HG17, 18HG21, 18HG29, 18HG30, 18HG31, 18IG10, 18IG14, 18IG17, 18IG20, 18JG02, 18JG03, 18JG16, 18JG19, 18JG20, 18JG35, 18JG37, 18KG01, 18KG17, 18KG19, 18KG36, 18KG39, 18KG41, 18LG12, 18LG14, 18LG30, 18LG39, 19AG01, 19AG17, 19AG19, 19AG29, 19BG02, 19BG18, 19BG19, 19BG32, 19BG33, 19CG01, 19CT26, 19CT33, 19CT53, 19CT56, 19CT80, 19DT05, 19DT30, 19DT46, 19ET18, 19ET34, 19ET39, 19ET40, 19ET61, 19ET65, 19ET69, 19FT01, 19FT41, 19GT13, 19HT68, 19IT01, 19IT15, 19IT53, 19IT54, 19JT06, 19JT10, 19JT14, 19JT56, 19JT63, 19KT02, 19KT14, 19KT38, 19KT41, 19LT16, 19LT21, 19LT36, 20AT22, 20BT02, 20CT02, 20CT05, 20CT11, 20CT14, 20CT32, 20DT19, 20DT20, 20DT23, 20DT29, 20DT32, 20DT35, 20ET33, 20ET34, 20ET38, 20ET39, 20ET49, 20FT17, 20FT18, 20FT60, 20GT34, KME20H0612, KME20H1787, KME20H2570, KME20H2572, KME20H2573, KME20H3001, KME20H3127, KME20H3128, KME20J1211, KME20J1389, KME21A1007, KME21A1008, KME21A1182, KME21A2025, KME21A2026, KME21A2189, KME21A3059, KME21A3060, KME21A3083, KME21A3084, KME21B0258, KME21B0790, KME21B1083, KME21B1259, KME21B1289, KME21B1545, KME21B1605, KME21B1754, KME21B2217, KME21B2530, KME21B2672, KME21C0424, KME21C0425, KME21C2416, KME21J1495, KME21K1633, KME21K1715, KME21K1842, KME21K1866, KME21K2302, KME21K2458, KME21K2459, KME21K2495, KME21K2579, KME21K2998, KME21K3000, KME21K3001, KME21L0074, KME21L0890, KME21L1033, KME21L1359, KME21L1364, KME21L1365, KME21L1435, KME21L1525, KME21L2143, KME21L2788, KME21M0949, KME21M1654, KME21M1655, KME21M1656, KME21M1906, KME21M1907, KME21M2271, KME21M2424, KME21M2479, KME21M2674, KME21M2706, KME21M2909, KME22A0562, KME22A1471, KME22A2179, KME22A2917, KME22A3198, KME22A3264, KME22B0005, KME22B0167, KME22B0191, KME22B0239, KME22B0277, KME22B0358, KME22B0399, KME22B0502, KME22B0580, KME22B1038, KME22B1144, KME22B1145, KME22B1224, KME22B1265, KME22B1309, KME22B1341, KME22B1418, KME22C0060, KME22C0494, KME22C0791, KME22C0792, KME22C1080, KME22C1081, KME22C1082, KME22C1236, KME22C1237, KME22C1472, KME22C1710, KME22C1711, KME22C1724, KME22C1850, KME22C1852, KME22C1878, KME22C1879, KME22C1880, KME22C1991, KME22C1992, KME22C2190, KME22C2968, KME22D0091, KME22D0153, KME22D0248, KME22D0285, KME22D0321, KME22D0444, KME22D0536, KME22D0717, KME22D1659, KME22D2057, KME22D2469, KME22D3211, KME22E1501, KME22E1932, KME22E2026, KME22E2122, KME22E2690, KME22E2805, KME22E2888, KME22E2928, KME22F0230, KME22F2072, KME22F2355, KME22F2625, KME22F3383, KME22F3502, KME22G0215, KME22G0234, KME22G0262, KME22G0476, KME22G0537, KME22G0735, KME22G0788, KME22G1047, KME22G1109, KME22G1332, KME22G1466, KME22G2049, KME22G2244, KME22G2774, KME22H1202. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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-1879-2023 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."
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      "@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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        "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
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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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