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  "name": "Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570",
  "description": "FDA recall Z-1849-2023 — TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 (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-1849-2023: TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570",
      "text": "The FDA logged enforcement record Z-1849-2023: TELEFLEX LLC is voluntarily recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 — 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 4026704547616, Batch Numbers:  18FG03, 18FG13, 18FG21, 18FG22, 18FG30, 18FT32, 18GG02, 18GG08, 18GG20, 18GT32, 18HG07, 18HG16, 18HG19, 18HG32, 18HG35, 18HG38, 18IG02, 18IG06, 18IG12, 18IG17, 18IG24, 18IG27, 18JG02, 18JG04, 18JG21, 18JG32, 18JG37, 18KG23, 18KG35, 18KG38, 18LG05, 18LG08, 18LG12, 18LG18, 18LG31, 18LG39, 19AG05, 19AG09, 19AG31, 19AG34, 19BG04, 19CG06, 19CT17, 19CT23, 19CT32, 19CT37, 19CT49, 19CT55, 19CT58, 19CT65, 19CT71, 19DT25, 19DT33, 19DT45, 19ET05, 19ET15, 19ET22, 19ET28, 19ET45, 19ET60, 19FT14, 19FT24, 19FT30, 19FT41, 19GT05, 19GT10, 19GT20, 19GT59, 19GT65, 19HT40, 19HT53, 19IT25, 19IT32, 19IT39, 19IT44, 19IT54, 19JT22, 19JT57, 19JT64, 19JT70, 19KT17, 19KT25, 19KT48, 19KT55, 19LT04, 19LT10, 19LT32, 19LT38, 19LT50, 20AT09, 20AT14, 20AT25, 20AT32, 20AT44, 20AT53, 20AT57, 20BG12, 20BT05, 20BT23, 20BT27, 20BT37, 20BT47, 20CT05, 20CT12, 20CT22, 20CT27, 20CT36, 20CT44, 20DT14, 20DT37, 20ET04, 20ET16, 20FT10, 20FT39, 20FT54, 20FT61, 20GG45, 20GG47, 20GT06, 20GT25, 20GT31, 20GT38, KME20H0972, KME20H1935, KME20H2588, KME20H2783, KME20J0058, KME20J0060, KME20J0156, KME20J0321, KME20J0573, KME20J0574, KME20J0803, KME20J0804, KME20J0805, KME20J0946, KME20J1112, KME20J1233, KME20J1692, KME20J1694, KME20J2175, KME20J2577, KME20J2957, KME20J3035, KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0943, KME20L0944, KME20L1091, KME20L1122, KME20L1124, KME20L1475, KME20L1844, KME20L2039, KME20L2258, KME20L2827, KME20M0378, KME20M0379, KME20M0380, KME20M0498, KME21G0508, KME21G1162, KME21G1179, KME21G1354, KME21G1355, KME21G1379, KME21G1385, KME21G1705, KME21G1782, KME21G2060, KME21G2061, KME21G2090, KME21H0604, KME21H0605, KME21H0607, KME21H0776, KME21H0777, KME21J1183, KME21J1206, KME21J1244, KME21J1255, KME21J1258, KME21J1482, KME21J1604, KME21J1747, KME21J2053, KME21K0016, KME21K0261, KME21K0271, KME21K0272, KME21K0314, KME21K0554, KME21K0662, KME21K0728, KME21K0830, KME21K1041, KME21K1044, KME21K1331, KME21K1413, KME21K1503, KME21K1517, KME21K1556, KME21K1620, KME21K1845, KME21K2355, KME21K2356, KME21L0093, KME21L0094, KME21L0768, KME21L1053, KME21L1054, KME21L1216, KME21L1217, KME21L1277, KME21L1966, KME21L2129, KME21L2690, KME21L2811, KME21M1888, KME21M2117, KME21M2320, KME21M2562, KME21M2845, KME21M3200, KME22A0150, KME22A0245, KME22A0390, KME22A0698, KME22A0797, KME22A0798, KME22A0990, KME22A1135, KME22A1161, KME22A1257, KME22A3253, KME22A3254, KME22A3312, KME22B0301, KME22B0354, KME22B0522, KME22B0523, KME22B0536, KME22B0537, KME22B0624, KME22B0633, KME22B0684, KME22B0849, KME22B0943, KME22B0985, KME22B1396, KME22B1408, KME22B1472, KME22B1560, KME22B1634, KME22B1636, KME22B1694, KME22B1752, KME22B1753, KME22B1793, KME22B1794, KME22B1873, KME22B2124, KME22B2125, KME22B2752, KME22B2884, KME22B2901, KME22C0067, KME22C0241, KME22C0532, KME22C0864, KME22C1020, KME22C1317, KME22C1860, KME22C1942, KME22C2352, KME22C2353, KME22C2649, KME22C2654, KME22C2723, KME22C2859, KME22C2987, KME22C2988, KME22C3185, KME22D0594, KME22D0711, KME22D0716, KME22D0831, KME22D0836, KME22D1498, KME22D1499, KME22D1964, KME22D1965, KME22D2545, KME22D2547, KME22D2548, KME22D2640, KME22D2738, KME22D2847, KME22D2848. 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-1849-2023 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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            "Field": "Initiated",
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}