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  "name": "Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050",
  "description": "FDA recall Z-1952-2023 — TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050 (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-1952-2023/enforcement-record",
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      "name": "FDA recall Z-1952-2023: TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050",
      "text": "The FDA logged enforcement record Z-1952-2023: TELEFLEX LLC is voluntarily recalling Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050 — 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 14026704341181, Batch Numbers:  18FG31, 18FT35, 18FT39, 18GG17, 18GG18, 18GT32, 18HG17, 18HG19, 18HG21, 18HG22, 18HG29, 18IG15, 18IG17, 18IG30, 18JG16, 18JG19, 18JG35, 18JG37, 18KG17, 18KG39, 18KG40, 18LG14, 18LG15, 18LG18, 18LG39, 19AG25, 19BG02, 19BG04, 19BG18, 19BG19, 19BG32, 19CG01, 19CT28, 19CT33, 19CT36, 19CT56, 19CT57, 19CT80, 19DT05, 19DT30, 19ET34, 19ET36, 19ET39, 19ET40, 19ET61, 19ET65, 19FT01, 19FT45, 19GT13, 19GT63, 19HT24, 19HT31, 19HT53, 19IT54, 19JT06, 19JT10, 19JT11, 19JT14, 19JT35, 19JT63, 19KT14, 19KT38, 19KT41, 19KT46, 19LT17, 19LT21, 20AT22, 20BT53, 20CT07, 20CT12, 20CT14, 20CT32, 20DT18, 20DT29, 20ET34, 20ET38, 20ET49, 20FT17, 20FT19, 20FT21, 20FT64, 20GT11, KME20J0370, KME20J0663, KME20J0665, KME20J1212, KME20K3628, KME20L2213, KME20L2286, KME20L2666, KME20L2668, KME20M0644, KME20M1284, KME20M2643, KME20M2645, KME20M2956, KME20M3015, KME21A1024, KME21A1065, KME21A1273, KME21A2079, KME21A2235, KME21A3066, KME21B0255, KME21B0256, KME21B0378, KME21B2209, KME21B2274, KME21B2275, KME21B2535, KME21C0433, KME21C0643, KME21C1123, KME21C1125, KME21C1164, KME21E0006, KME21F0902, KME21F1216, KME21F2139, KME21F2198, KME21J0892, KME21J1496, KME21J1690, KME21J1813, KME21J2074, KME21K0004, KME21K0115, KME21K0296, KME21K0875, KME21K0877, KME21K1029, KME21K1079, KME21K1716, KME21K1826, KME21K1868, KME21K2303, KME21K2335, KME21K3007, KME21L0889, KME21L0985, KME21L1526, KME21L1597, KME21L1776, KME21L2153, KME21L2154, KME21L2299, KME21L2885, KME21M0162, KME21M0337, KME21M0342, KME21M0502, KME21M0733, KME21M0951, KME21M1978, KME21M1979, KME21M2427, KME21M2675, KME21M2676, KME21M2711, KME21M2807, KME22A0564, KME22A0565, KME22A1888, KME22A2257, KME22A2369, KME22A2370, KME22A2850, KME22A2919, KME22A2970, KME22B0006, KME22B0174, KME22B0360, KME22B0400, KME22B0665, KME22B0754, KME22B2315, KME22B2554, KME22B2557, KME22B2631, KME22B2633, KME22B2635, KME22B2678, KME22B2793, KME22B2794, KME22B2920, KME22C0553, KME22C1122, KME22C3230, KME22C3394, KME22C3396, KME22D0097, KME22D0108, KME22D0244, KME22D0286, KME22D0322, KME22D0538, KME22D0539, KME22D0602, KME22D0805, KME22D0854, KME22D0936, KME22D1008, KME22D1453, KME22D1957, KME22D2058, KME22D2293, KME22D2643, KME22D2765, KME22D3013, KME22E0947, KME22E0956, KME22E1500, KME22E1885, KME22E2219, KME22E2220, KME22E2440, KME22E2512, KME22E2872, KME22F0074, KME22F0542, KME22F0987, KME22F1112, KME22F2173, KME22F2206. 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-1952-2023 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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        "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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