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  "name": "Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065",
  "description": "FDA recall Z-1887-2023 — TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 (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-1887-2023/enforcement-record",
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      "name": "FDA recall Z-1887-2023: TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065",
      "text": "The FDA logged enforcement record Z-1887-2023: TELEFLEX LLC is voluntarily recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 — 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 14026704341419, Batch Numbers:  18FG23, 18FG27, 18FG30, 18FG31, 18FT06, 18FT08, 18GG19, 18GT32, 18GT34, 18HG02, 18HG15, 18IG02, 18IG07, 18IG13, 18IT25, 18JG01, 18JG02, 18JG04, 18JG07, 18JG20, 18KG44, 18KT28, 18LG14, 19AG09, 19AG15, 19AG32, 19AG33, 19AT20, 19BG14, 19BG18, 19BG40, 19CG07, 19CT26, 19CT39, 19CT40, 19CT76, 19DT10, 19DT16, 19DT27, 19DT47, 19ET02, 19ET05, 19ET65, 19GT19, 19GT29, 19GT30, 19GT31, 19GT38, 19HT26, 19HT61, 19HT66, 19HT68, 19IT20, 19IT33, 19IT59, 19JT18, 19JT19, 19JT26, 19JT32, 19JT36, 19JT49, 19JT63, 19KT20, 19KT21, 19KT26, 19LT07, 19LT31, 19LT46, 20AT05, 20AT06, 20AT20, 20AT47, 20AT49, 20BT13, 20CT02, 20CT13, 20CT23, 20CT37, 20CT47, 20CT54, 20DT01, 20DT02, 20ET16, 20ET18, 20GT05, 20GT06, 20GT13, 20GT22, 20GT24, KME20H0882, KME20H2726, KME20H2934, KME20J1386, KME20J1399, KME20J1656, KME20K0036, KME20K0259, KME20K0436, KME20K0504, KME20K0677, KME20K0881, KME20L2349, KME20L2447, KME20L2448, KME20M0710, KME20M0892, KME20M0928, KME20M1806, KME20M1923, KME20M2249, KME20M2450, KME20M2708, KME21A0338, KME21A0404, KME21A0695, KME21B1352, KME21B2607, KME21B2789, KME21C0504, KME21C0981, KME21C0983, KME21C1035, KME21C1097, KME21E0607, KME21E0685, KME21F0384, KME21F0516, KME21F0694, KME21F0834, KME21F0930, KME21F1554, KME21F1885, KME21F2156, KME21F2203, KME21G0532, KME21H0202, KME21H0916, KME21H1233, KME21H1264, KME21J0302, KME21J0389, KME21J0528, KME21J0637, KME21J0725, KME21J0909, KME21J1871, KME21J1945, KME21J1998, KME21K0570, KME21K0587, KME21K0829, KME21L0344, KME21L0408, KME21L0566, KME21L1306, KME21L2132, KME21L2653, KME21M0853, KME21M1380, KME21M1469, KME22A0676, KME22A1234, KME22A1388, KME22A1505, KME22A2005, KME22A2059, KME22A2198, KME22A2316, KME22A2350, KME22A2401, KME22A2481, KME22A2694, KME22A2959, KME22A3224, KME22B0070, KME22B0466, KME22B0566, KME22B0946, KME22B1049, KME22B1945, KME22B2102, KME22B2322, KME22B2644, KME22C2076, KME22D0407, KME22D0573, KME22D0810, KME22D1482, KME22D1780, KME22D2011, KME22D2630, KME22D3020, KME22E1854, KME22E2488, KME22F1264, KME22F2116, KME22F2172, KME22F2296, KME22F2720, KME22G0552, KME22G2426, KME22G2943, KME22H0766, KME22H1917, KME22H2054. 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-1887-2023 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1887-2023/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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            "Value": "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.",
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            "Field": "Distribution pattern",
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