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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;   b)\t3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030;   c)\t3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035;   d)\t4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040;   e)\t2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025;   f)\t3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030;   g)\t3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035;   h)\t4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040;   i)\t4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045;   j)\t5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050;   k)\t5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055",
  "description": "FDA recall Z-2602-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;   b)\t3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030;   c)\t3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035;   d)\t4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040;   e)\t2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025;   f)\t3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030;   g)\t3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035;   h)\t4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040;   i)\t4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045;   j)\t5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050;   k)\t5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055 (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;   b)\t3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030;   c)\t3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035;   d)\t4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040;   e)\t2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025;   f)\t3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030;   g)\t3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035;   h)\t4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040;   i)\t4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045;   j)\t5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050;   k)\t5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055",
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      "name": "FDA recall Z-2602-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;   b)\t3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030;   c)\t3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035;   d)\t4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040;   e)\t2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025;   f)\t3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030;   g)\t3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035;   h)\t4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040;   i)\t4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045;   j)\t5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050;   k)\t5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055",
      "text": "The FDA logged enforcement record Z-2602-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\t2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025;   b)\t3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030;   c)\t3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035;   d)\t4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040;   e)\t2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025;   f)\t3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030;   g)\t3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035;   h)\t4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040;   i)\t4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045;   j)\t5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050;   k)\t5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055 — 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 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers:  3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056;  b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers:  3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805;  c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers:  3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930,  d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers:  3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789;  e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers:  3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 4327884, 4335084, 4345045, 4365784;  f) UDI/DI 15021312000368, Product Code/List Number/Item Code 60SP030, Lot Numbers:  , 3853491, 3853492, 3868316, 3877643, 3884256, 3894888, 3923735, 3952385, 3955780, 3965909, 3982711, 4001220, 4015600, 4021423, 4024939, 4051655, 4060225, 4077113, 4083929, 4086024, 4107575, 4116084, 4122451, 4131002, 4139003, 4142430, 4153593, 4161992, 4168181, 4171559, 4176237, 4185437, 4196300, 4204828, 4206846, 4209590, 4217452, 4221361, 4247296, 4254287, 4279350, 4283260, 4286823, 4335085, 4345046, 4369626, 4374484, 4382718, 4388214, 4389931, 4395806, 4400704;  g) UDI/DI 15021312000375, Product Code/List Number/Item Code 60SP035, Lot Numbers:  3840044, 3853493, 3853494, 3868228, 3868229, 3884268, 3897848, 3907968, 3911420, 3926971, 3949027, 3952407, 3952408, 3955774, 3965910, 3982712, 3988164, 3988165, 3991210, 4005685, 4012662, 4018528, 4026679, 4034946, 4034947, 4056229, 4066278, 4077085, 4083940, 4085994, 4095919, 4107587, 4110471, 4119115, 4130987, 4139019, 4145700, 4151028, 4156660, 4161959, 4161960, 4176210, 4197629, 4206847, 4209591, 4212794, 4218724, 4226272, 4233983, 4240167, 4254288, 4260080, 4276485, 4283261, 4286824, 4289500, 4292185, 4322693, 4322695, 4335086, 4335087, 4335088, 4351253, 4352807, 4369623, 4369624, 4369625, 4382710, 4388215, 4389932, 4393428, 4393429;  h) UDI/DI 15021312000382, Product Code/List Number/Item Code 60SP040, Lot Numbers:  3840061, 3853495, 3853496, 3861152, 3868210, 3868211, 3868212, 3894897, 3897846, 3907967, 3911423, 3930038, 3936574, 3946288, 3946289, 3946290, 3948791, 3949042, 3952338, 3952339, 3952340, 3955796, 3955797, 3982713, 3988166, 3991211, 3991212, 3997825, 4001221, 4015603, 4015605, 4015606, 4015608, 4026691, 4035769, 4041966, 4051661, 4056239, 4063194, 4070854, 4077066, 4083936, 4089288, 4092646, 4100889, 4107586, 4113097, 4119109, 4122427, 4130975, 4134011, 4142438, 4145678, 4151024, 4153604, 4159987, 4163838, 4171562, 4171563, 4176204, 4179372, 4185438, 4196301, 4201398, 4204829, 4206848, 4209592, 4212795, 4218725, 4221362, 4237399, 4240168, 4240169, 4254289, 4254290, 4273444, 4276486, 4283262, 4286825, 4289501, 4322696, 4322697, 4327952, 4335089, 4335090, 4348790, 4348791, 4351254, 4352806, 4353058, 4369629, 4369630, 4374485, 4374486, 4380061, 4383660, 4383661, 4388216, 4389933;  i) UDI/DI 15021312000399, Product Code/List Number/Item Code 60SP045, Lot Numbers:  3840064, 3853497, 3868193, 3868194, 3868196, 3887754, 3894901, 3897885, 3911439, 3930048, 3942488, 3948793, 3952352, 3952353, 3952354, 3955808, 3959300, 3962575, 3982714, 3997826, 4001222, 4011387, 4015609, 4015610, 4035770, 4051647, 4056253, 4066297, 4077080, 4080782, 4089290, 4095915, 4105247, 4113116, 4119114, 4122452, 4130985, 4142432, 4145695, 4147994, 4153601, 4159988, 4161995, 4161996, 4168146, 4179373, 4185439, 4197630, 4201400, 4204830, 4209595, 4212796, 4216339, 4217453, 4221363, 4233984, 4233987, 4237400, 4254291, 4260081, 4276487, 4283263, 4286826, 4289502, 4335091, 4335092, 4345047, 4348793, 4348794, 4348795, 4348796, 4357227, 4357228, 4362881, 4362882, 4374487, 4381039, 4382711, 4383662, 4388217, 4388218, 4389934, 4393431, 4399221;  j) UDI/DI 15021312000405, Product Code/List Number/Item Code 60SP050, Lot Numbers:  3840086, 3853498, 3868219, 3887748, 3897855, 3907970, 3942494, 3949034, 3952382, 3952383, 3962579, 3982715, 3988167, 3997827, 4001223, 4015611, 4015613, 4027992, 4027993, 4040760, 4053719, 4066285, 4089299, 4100886, 4113120, 4125829, 4134017, 4145722, 4147983, 4156662, 4163817, 4173738, 4179374, 4180461, 4196302, 4206849, 4209593, 4216340, 4218726, 4233986, 4254292, 4254293, 4273445, 4276488, 4279351, 4289503, 4322699, 4327950, 4335093, 4351255, 4352805, 4369627, 4369628, 4374488, 4380062, 4383663, 4388219, 4388220, 4389935, 4399222, 4400710;  k) UDI/DI 15021312000436, Product Code/List Number/Item Code 60SP055, Lot Numbers:  3868322, 3901294, 3911430, 3936571, 3942470, 3948792, 3952344, 3952345, 3982716, 3988168, 3991214, 3991215, 4015615, 4015617, 4051626, 4066279, 4092632, 4110472, 4122437, 4128020, 4134026, 4145711, 4156618, 4161972, 4173739, 4180496, 4206851, 4209594, 4212797, 4223744, 4233985, 4247297, 4276489, 4279352, 4292186, 4322700, 4327889, 4335094, 4351256, 4374489, 4374490, 4380063, 4399223. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2602-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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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      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2602-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2602-2024&lang=eng",
        "value": "Class I",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2602-2024&lang=eng"
        }
      },
      "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-2602-2024/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
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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": "Lot/code info",
            "Value": "a) UDI/DI 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers:  3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056;  b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers:  3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805;  c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers:  3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930,  d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers:  3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789;  e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers:  3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 4327884, 4335084, 4345045, 4365784;  f) UDI/DI 15021312000368, Product Code/List Number/Item Code 60SP030, Lot Numbers:  , 3853491, 3853492, 3868316, 3877643, 3884256, 3894888, 3923735, 3952385, 3955780, 3965909, 3982711, 4001220, 4015600, 4021423, 4024939, 4051655, 4060225, 4077113, 4083929, 4086024, 4107575, 4116084, 4122451, 4131002, 4139003, 4142430, 4153593, 4161992, 4168181, 4171559, 4176237, 4185437, 4196300, 4204828, 4206846, 4209590, 4217452, 4221361, 4247296, 4254287, 4279350, 4283260, 4286823, 4335085, 4345046, 4369626, 4374484, 4382718, 4388214, 4389931, 4395806, 4400704;  g) UDI/DI 15021312000375, Product Code/List Number/Item Code 60SP035, Lot Numbers:  3840044, 3853493, 3853494, 3868228, 3868229, 3884268, 3897848, 3907968, 3911420, 3926971, 3949027, 3952407, 3952408, 3955774, 3965910, 3982712, 3988164, 3988165, 3991210, 4005685, 4012662, 4018528, 4026679, 4034946, 4034947, 4056229, 4066278, 4077085, 4083940, 4085994, 4095919, 4107587, 4110471, 4119115, 4130987, 4139019, 4145700, 4151028, 4156660, 4161959, 4161960, 4176210, 4197629, 4206847, 4209591, 4212794, 4218724, 4226272, 4233983, 4240167, 4254288, 4260080, 4276485, 4283261, 4286824, 4289500, 4292185, 4322693, 4322695, 4335086, 4335087, 4335088, 4351253, 4352807, 4369623, 4369624, 4369625, 4382710, 4388215, 4389932, 4393428, 4393429;  h) UDI/DI 15021312000382, Product Code/List Number/Item Code 60SP040, Lot Numbers:  3840061, 3853495, 3853496, 3861152, 3868210, 3868211, 3868212, 3894897, 3897846, 3907967, 3911423, 3930038, 3936574, 3946288, 3946289, 3946290, 3948791, 3949042, 3952338, 3952339, 3952340, 3955796, 3955797, 3982713, 3988166, 3991211, 3991212, 3997825, 4001221, 4015603, 4015605, 4015606, 4015608, 4026691, 4035769, 4041966, 4051661, 4056239, 4063194, 4070854, 4077066, 4083936, 4089288, 4092646, 4100889, 4107586, 4113097, 4119109, 4122427, 4130975, 4134011, 4142438, 4145678, 4151024, 4153604, 4159987, 4163838, 4171562, 4171563, 4176204, 4179372, 4185438, 4196301, 4201398, 4204829, 4206848, 4209592, 4212795, 4218725, 4221362, 4237399, 4240168, 4240169, 4254289, 4254290, 4273444, 4276486, 4283262, 4286825, 4289501, 4322696, 4322697, 4327952, 4335089, 4335090, 4348790, 4348791, 4351254, 4352806, 4353058, 4369629, 4369630, 4374485, 4374486, 4380061, 4383660, 4383661, 4388216, 4389933;  i) UDI/DI 15021312000399, Product Code/List Number/Item Code 60SP045, Lot Numbers:  3840064, 3853497, 3868193, 3868194, 3868196, 3887754, 3894901, 3897885, 3911439, 3930048, 3942488, 3948793, 3952352, 3952353, 3952354, 3955808, 3959300, 3962575, 3982714, 3997826, 4001222, 4011387, 4015609, 4015610, 4035770, 4051647, 4056253, 4066297, 4077080, 4080782, 4089290, 4095915, 4105247, 4113116, 4119114, 4122452, 4130985, 4142432, 4145695, 4147994, 4153601, 4159988, 4161995, 4161996, 4168146, 4179373, 4185439, 4197630, 4201400, 4204830, 4209595, 4212796, 4216339, 4217453, 4221363, 4233984, 4233987, 4237400, 4254291, 4260081, 4276487, 4283263, 4286826, 4289502, 4335091, 4335092, 4345047, 4348793, 4348794, 4348795, 4348796, 4357227, 4357228, 4362881, 4362882, 4374487, 4381039, 4382711, 4383662, 4388217, 4388218, 4389934, 4393431, 4399221;  j) UDI/DI 15021312000405, Product Code/List Number/Item Code 60SP050, Lot Numbers:  3840086, 3853498, 3868219, 3887748, 3897855, 3907970, 3942494, 3949034, 3952382, 3952383, 3962579, 3982715, 3988167, 3997827, 4001223, 4015611, 4015613, 4027992, 4027993, 4040760, 4053719, 4066285, 4089299, 4100886, 4113120, 4125829, 4134017, 4145722, 4147983, 4156662, 4163817, 4173738, 4179374, 4180461, 4196302, 4206849, 4209593, 4216340, 4218726, 4233986, 4254292, 4254293, 4273445, 4276488, 4279351, 4289503, 4322699, 4327950, 4335093, 4351255, 4352805, 4369627, 4369628, 4374488, 4380062, 4383663, 4388219, 4388220, 4389935, 4399222, 4400710;  k) UDI/DI 15021312000436, Product Code/List Number/Item Code 60SP055, Lot Numbers:  3868322, 3901294, 3911430, 3936571, 3942470, 3948792, 3952344, 3952345, 3982716, 3988168, 3991214, 3991215, 4015615, 4015617, 4051626, 4066279, 4092632, 4110472, 4122437, 4128020, 4134026, 4145711, 4156618, 4161972, 4173739, 4180496, 4206851, 4209594, 4212797, 4223744, 4233985, 4247297, 4276489, 4279352, 4292186, 4322700, 4327889, 4335094, 4351256, 4374489, 4374490, 4380063, 4399223",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}