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  "name": "Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075",
  "description": "FDA recall Z-1889-2023 — TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 (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-1889-2023/enforcement-record",
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      "name": "FDA recall Z-1889-2023: TELEFLEX LLC is recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075",
      "text": "The FDA logged enforcement record Z-1889-2023: TELEFLEX LLC is voluntarily recalling Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 — 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 14026704341433, Batch Numbers:  18FG29, 18GG13, 18GG15, 18GG26, 18GT32, 18GT34, 18HG14, 18HG21, 18HG23, 18HG24, 18HG27, 18HT15, 18HT31, 18IG25, 18IG29, 18IT04, 18IT23, 18IT25, 18JG10, 18JT22, 18KG05, 18KT11, 18LG19, 18LG38, 18LG40, 18LT07, 19AG21, 19BG01, 19BG04, 19BG06, 19BG37, 19BT04, 19BT12, 19BT18, 19CG04, 19CG06, 19CT03, 19CT04, 19CT20, 19CT26, 19CT34, 19CT42, 19CT50, 19CT57, 19CT64, 19CT69, 19DT10, 19DT34, 19DT36, 19DT42, 19ET02, 19ET06, 19ET08, 19ET22, 19ET29, 19ET34, 19ET36, 19ET70, 19ET72, 19ET82, 19FT04, 19FT25, 19FT33, 19GT02, 19GT14, 19GT16, 19GT25, 19GT29, 19GT64, 19HT03, 19HT09, 19HT15, 19HT71, 19IT12, 19IT13, 19IT41, 19IT42, 19IT45, 19JT11, 19JT14, 19KT26, 19KT35, 19KT48, 19KT49, 19LT07, 19LT23, 19LT31, 19LT35, 19LT54, 20AT11, 20AT20, 20AT22, 20AT26, 20AT47, 20AT58, 20BT01, 20BT25, 20BT31, 20BT39, 20BT50, 20BT51, 20CT42, 20CT43, 20CT51, 20CT53, 20CT54, 20DT01, 20DT32, 20DT37, 20ET12, 20FT35, 20FT36, 20FT39, 20FT43, 20FT49, 20FT53, 20FT55, 20FT71, 20GG41, 20GG42, 20GT10, 20GT11, 20GT14, 20GT25, 20GT41, 20GT51, 20GT57, KME20J2944, KME20J2988, KME20K1113, KME20L1298, KME20L1299, KME20L1704, KME20L1924, KME20L1983, KME20L2605, KME20L2798, KME20M0034, KME20M0321, KME20M1067, KME20M1507, KME21A3004, KME21A3259, KME21B0179, KME21B0823, KME21B2480, KME21C0615, KME21C0661, KME21C0730, KME21C0826, KME21C0855, KME21C2026, KME21D1923, KME21D1956, KME21D2014, KME21D2018, KME21D2262, KME21E0021, KME21E0288, KME21E0469, KME21E0498, KME21E1186, KME21E1264, KME21F0385, KME21F0557, KME21F0725, KME21F1583, KME21F1607, KME21F1696, KME21F1751, KME21F2182, KME21G0114, KME21G0169, KME21G1942, KME21H0829, KME21J0200, KME21J0359, KME21J0418, KME21J0671, KME21J0763, KME21J1212, KME21J1709, KME21J1842, KME21K0305, KME21K0986, KME21K1712, KME21K1855, KME21K2531, KME21K2745, KME21L0628, KME21L0880, KME21L1025, KME21L1443, KME21L1581, KME21L1663, KME21L1698, KME21L1992, KME21L2222, KME21L2455, KME21L2775, KME21M0193, KME21M0314, KME21M0500, KME21M0690, KME21M0802, KME21M0852, KME21M1006, KME21M1065, KME21M1085, KME21M1245, KME21M1268, KME21M1583, KME21M1613, KME21M1749, KME21M2745, KME21M2871, KME22A0545, KME22A0854, KME22A0940, KME22A1136, KME22A1224, KME22A1367, KME22A1392, KME22A1990, KME22A2129, KME22A2315, KME22A2414, KME22A2537, KME22A2602, KME22A2603, KME22A2898, KME22A2937, KME22A3082, KME22A3219, KME22A3222, KME22A3238, KME22B0266, KME22C2126, KME22C2350, KME22C2437, KME22C2439, KME22C2756, KME22C2855, KME22C3145, KME22D0324, KME22D0464, KME22D1176, KME22D1481, KME22D1660, KME22D1688, KME22D2635, KME22D2853, KME22D3116, KME22D3236, KME22D3419, KME22D3420, KME22D3711, KME22E0179, KME22E0319, KME22E0321, KME22E0322, KME22E0641, KME22E0642, KME22E2647, KME22E3002, KME22F0185, KME22F0317, KME22F0775, KME22F1265, KME22F2028, KME22F2237, KME22F2721, KME22J1258, KME22J3143, KME22J3344. 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-1889-2023 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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      "reviewStatus": "current",
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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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            "Field": "Initiated",
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