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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS30;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS35;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS40;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS45;   f)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS50;   g)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS55",
  "description": "FDA recall Z-2613-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS30;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS35;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS40;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS45;   f)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS50;   g)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS55 (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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    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS30;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS35;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS40;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS45;   f)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS50;   g)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS55",
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      "name": "FDA recall Z-2613-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS30;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS35;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS40;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS45;   f)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS50;   g)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS55",
      "text": "The FDA logged enforcement record Z-2613-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25;   b)\tPEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS30;   c)\tPEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS35;   d)\tPEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS40;   e)\tPEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS45;   f)\tPEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS50;   g)\tPEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK  , Product Code/List Number/Item Code 67PFS55 — reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-29. Affected lots/codes: a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers:  3961256, 4119091, 4213406, 4374410, 4395754;  b) UDI/DI 10351688518606, Product Code/List Number/Item Code 67PFS30, Lot Numbers:  3853403, 3874324, 3884244, 3907973, 3930052, 3959311, 3961752, 4060198, 4083906, 4091413, 4105249, 4107582, 4116088, 4138998, 4145680, 4180479, 4213407, 4328215, 4334909, 4348419, 4380074, 4388119, 4395755, 4400635;   c) UDI/DI 10351688518613, Product Code/List Number/Item Code 67PFS35, Lot Numbers:  3853405, 3868268, 3871039, 3877670, 3887715, 3897877, 3914571, 3923745, 3936566, 3939652, 3942529, 3952412, 3959318, 3959319, 3981991, 3981992, 3997804, 4005592, 4015530, 4018503, 4026671, 4029496, 4033708, 4041961, 4048011, 4051671, 4053726, 4060196, 4077102, 4083926, 4089293, 4095927, 4110435, 4119103, 4125804, 4136125, 4145702, 4153579, 4161986, 4173727, 4180483, 4213408, 4217433, 4221336, 4237359, 4260057, 4279323, 4328216, 4334912, 4334915, 4352772, 4365786, 4369563, 4383606, 4388120, 4389875, 4393393, 4399138;  d) UDI/DI 10351688518620, Product Code/List Number/Item Code 67PFS40, Lot Numbers:  3835787, 3853406, 3864263, 3864264, 3877654, 3884237, 3894877, 3901287, 3918018, 3920960, 3930015, 3931145, 3936583, 3939681, 3942528, 3952397, 3952398, 3959325, 3962585, 3981993, 3997805, 4008201, 4015531, 4029497, 4033709, 4035707, 4043938, 4051619, 4056251, 4060221, 4080783, 4086001, 4100895, 4107581, 4119124, 4136126, 4142427, 4145681, 4151010, 4156606, 4161963, 4171578, 4180476, 4213409, 4221337, 4237360, 4240130, 4254221, 4276451, 4283222, 4328217, 4331573, 4334920, 4344978, 4357248, 4362850, 4369572, 4388122, 4389876, 4395758, 4399139;  e) UDI/DI 10351688518637, Product Code/List Number/Item Code 67PFS45, Lot Numbers:  3861137, 3868253, 3880679, 3887722, 3887723, 3904686, 3923731, 3936584, 3942523, 3952394, 3962590, 3981994, 3991132, 3997806, 4005593, 4018504, 4029498, 4041962, 4051665, 4060195, 4063170, 4077101, 4083932, 4089305, 4092641, 4097828, 4100890, 4119096, 4122440, 4130981, 4142451, 4151051, 4161982, 4171579, 4179342, 4217434, 4237361, 4240131, 4260058, 4276452, 4328218, 4334921, 4344979, 4355426, 4380075, 4383607, 4388123, 4389877, 4395761, 4399140;  f) UDI/DI 10351688518644, Product Code/List Number/Item Code 67PFS50, Lot Numbers:  3868275, 3868276, 3874297, 3880681, 3894878, 3897867, 3918019, 3923726, 3930016, 3939676, 3942518, 3942519, 3952392, 3959323, 3962589, 3981995, 3987958, 4005595, 4011364, 4018505, 4029499, 4035708, 4053704, 4063171, 4077073, 4089307, 4097830, 4110436, 4116105, 4128042, 4136132, 4145688, 4153624, 4159962, 4179343, 4180474, 4213410, 4221338, 4283223, 4286795, 4322659, 4329838, 4334220, 4362864, 4388124, 4388125, 4388126, 4393394;  g) UDI/DI 10351688518651, Product Code/List Number/Item Code 67PFS55, Lot Numbers:  3853408, 3864260, 3871050, 3877655, 3884263, 3891530, 3904671, 3904672, 3920942, 3930012, 3939670, 3939671, 3952349, 3965908, 3981996, 4008202, 4015532, 4018506, 4026690, 4035709, 4048025, 4053734, 4063172, 4077089, 4083905, 4096833, 4107580, 4110437, 4128016, 4138999, 4142428, 4151012, 4159955, 4163853, 4173728, 4179344, 4185410, 4196262, 4213411, 4279324, 4286796, 4331580, 4334931, 4352773, 4374411, 4380999, 4388127, 4389878, 4395762, 4399141. 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2613-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2613-2024 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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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class I",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2613-2024/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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        "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
      },
      "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": "Ongoing — the recall is still being carried out.",
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            "Status": "recorded"
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            "Value": "Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.",
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            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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            "Value": "a) UDI/DI 10351688518590, Product Code/List Number/Item Code 67PFS25, Lot Numbers:  3961256, 4119091, 4213406, 4374410, 4395754;  b) UDI/DI 10351688518606, Product Code/List Number/Item Code 67PFS30, Lot Numbers:  3853403, 3874324, 3884244, 3907973, 3930052, 3959311, 3961752, 4060198, 4083906, 4091413, 4105249, 4107582, 4116088, 4138998, 4145680, 4180479, 4213407, 4328215, 4334909, 4348419, 4380074, 4388119, 4395755, 4400635;   c) UDI/DI 10351688518613, Product Code/List Number/Item Code 67PFS35, Lot Numbers:  3853405, 3868268, 3871039, 3877670, 3887715, 3897877, 3914571, 3923745, 3936566, 3939652, 3942529, 3952412, 3959318, 3959319, 3981991, 3981992, 3997804, 4005592, 4015530, 4018503, 4026671, 4029496, 4033708, 4041961, 4048011, 4051671, 4053726, 4060196, 4077102, 4083926, 4089293, 4095927, 4110435, 4119103, 4125804, 4136125, 4145702, 4153579, 4161986, 4173727, 4180483, 4213408, 4217433, 4221336, 4237359, 4260057, 4279323, 4328216, 4334912, 4334915, 4352772, 4365786, 4369563, 4383606, 4388120, 4389875, 4393393, 4399138;  d) UDI/DI 10351688518620, Product Code/List Number/Item Code 67PFS40, Lot Numbers:  3835787, 3853406, 3864263, 3864264, 3877654, 3884237, 3894877, 3901287, 3918018, 3920960, 3930015, 3931145, 3936583, 3939681, 3942528, 3952397, 3952398, 3959325, 3962585, 3981993, 3997805, 4008201, 4015531, 4029497, 4033709, 4035707, 4043938, 4051619, 4056251, 4060221, 4080783, 4086001, 4100895, 4107581, 4119124, 4136126, 4142427, 4145681, 4151010, 4156606, 4161963, 4171578, 4180476, 4213409, 4221337, 4237360, 4240130, 4254221, 4276451, 4283222, 4328217, 4331573, 4334920, 4344978, 4357248, 4362850, 4369572, 4388122, 4389876, 4395758, 4399139;  e) UDI/DI 10351688518637, Product Code/List Number/Item Code 67PFS45, Lot Numbers:  3861137, 3868253, 3880679, 3887722, 3887723, 3904686, 3923731, 3936584, 3942523, 3952394, 3962590, 3981994, 3991132, 3997806, 4005593, 4018504, 4029498, 4041962, 4051665, 4060195, 4063170, 4077101, 4083932, 4089305, 4092641, 4097828, 4100890, 4119096, 4122440, 4130981, 4142451, 4151051, 4161982, 4171579, 4179342, 4217434, 4237361, 4240131, 4260058, 4276452, 4328218, 4334921, 4344979, 4355426, 4380075, 4383607, 4388123, 4389877, 4395761, 4399140;  f) UDI/DI 10351688518644, Product Code/List Number/Item Code 67PFS50, Lot Numbers:  3868275, 3868276, 3874297, 3880681, 3894878, 3897867, 3918019, 3923726, 3930016, 3939676, 3942518, 3942519, 3952392, 3959323, 3962589, 3981995, 3987958, 4005595, 4011364, 4018505, 4029499, 4035708, 4053704, 4063171, 4077073, 4089307, 4097830, 4110436, 4116105, 4128042, 4136132, 4145688, 4153624, 4159962, 4179343, 4180474, 4213410, 4221338, 4283223, 4286795, 4322659, 4329838, 4334220, 4362864, 4388124, 4388125, 4388126, 4393394;  g) UDI/DI 10351688518651, Product Code/List Number/Item Code 67PFS55, Lot Numbers:  3853408, 3864260, 3871050, 3877655, 3884263, 3891530, 3904671, 3904672, 3920942, 3930012, 3939670, 3939671, 3952349, 3965908, 3981996, 4008202, 4015532, 4018506, 4026690, 4035709, 4048025, 4053734, 4063172, 4077089, 4083905, 4096833, 4107580, 4110437, 4128016, 4138999, 4142428, 4151012, 4159955, 4163853, 4173728, 4179344, 4185410, 4196262, 4213411, 4279324, 4286796, 4331580, 4334931, 4352773, 4374411, 4380999, 4388127, 4389878, 4395762, 4399141",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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