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  "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55",
  "description": "FDA recall Z-2599-2024 — Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55",
    "manufacturer": {
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      "name": "Smiths Medical ASD Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2599-2024/enforcement-record",
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      "name": "FDA recall Z-2599-2024: Smiths Medical ASD Inc. is recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55",
      "text": "The FDA logged enforcement record Z-2599-2024: Smiths Medical ASD Inc. is voluntarily recalling PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55 — 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 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers:   3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474;  b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers:  3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668;  c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers:  3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702, 3884241, 3887745, 3891532, 3901293, 3904667, 3907987, 3917981, 3920937, 3920938, 3930041, 3936575, 3942465, 3942466, 3942467, 3942468, 3946228, 3946229, 3946230, 3946231, 3955802, 3962598, 3962599, 3982671, 3982672, 3988094, 3988095, 3988096, 3988097, 3991159, 3991160, 3991161, 3991162, 4005651, 4005654, 4008218, 4008219, 4015546, 4015547, 4021418, 4026694, 4033724, 4035743, 4048010, 4051625, 4053720, 4056230, 4060212, 4060213, 4063185, 4071981, 4075241, 4083914, 4089301, 4092633, 4097833, 4105259, 4107594, 4110454, 4116094, 4122438, 4128018, 4130990, 4134027, 4145710, 4148001, 4151036, 4153618, 4156615, 4159944, 4163822, 4163823, 4176221, 4179357, 4185420, 4196279, 4197615, 4201384, 4204817, 4206819, 4209565, 4216323, 4217444, 4218707, 4221345, 4223730, 4231501, 4233963, 4233964, 4240150, 4254247, 4260068, 4273426, 4279333, 4283240, 4286802, 4289480, 4292167, 4292168, 4331613, 4331614, 4335008, 4335009, 4335010, 4335011, 4345012, 4352785, 4352786, 4360406, 4360407, 4360408, 4369596, 4369598, 4374441, 4374442, 4374443, 4381018, 4381019, 4381020, 4383627, 4383628, 4383632, 4388169, 4388170, 4388171, 4388172, 4393410;  d) UDI/DI 15021312005868, Product Code/List Number/Item Code 60PFS40, Lot Numbers:  3835740, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3871061, 3880721, 3880722, 3884259, 3887731, 3894886, 3894887, 3897887, 3901308, 3907996, 3907997, 3918003, 3920955, 3942503, 3942504, 3942505, 3942506, 3946268, 3946269, 3946270, 3955782, 3955783, 3955784, 3955785, 3959304, 3959305, 3962576, 3982674, 3982679, 3982680, 3982683, 3988100, 3988101, 3988102, 3991164, 3991165, 3991166, 3991167, 3991168, 4005655, 4005656, 4005662, 4005664, 4005665, 4005666, 4015548, 4015549, 4015550, 4033725, 4048022, 4051650, 4051651, 4053718, 4056236, 4056237, 4063186, 4063187, 4071985, 4071986, 4075242, 4077110, 4080791, 4089309, 4093736, 4107572, 4107573, 4113115, 4119101, 4122448, 4128031, 4139013, 4145719, 4151013, 4153596, 4159975, 4161991, 4163834, 4171552, 4176239, 4179358, 4180464, 4185421, 4185422, 4185423, 4204818, 4206820, 4209566, 4209567, 4212780, 4216324, 4218708, 4221346, 4231502, 4233965, 4233967, 4234639, 4237385, 4240151, 4254248, 4260069, 4273427, 4279334, 4283241, 4286803, 4286804, 4289481, 4289482, 4292169, 4292170, 4322675, 4331615, 4335012, 4335013, 4335014, 4345013, 4345014, 4348476, 4348477, 4351240, 4355431, 4355432, 4357235, 4357236, 4357237, 4358510, 4365777, 4369600, 4379950, 4379960, 4381021, 4383629, 4383630, 4383631, 4388173, 4388174, 4388175, 4389901, 4389902, 4399188;  e) UDI/DI 15021312005875, Product Code/List Number/Item Code 60PFS45, Lot Numbers:  3843109, 3853462, 3868224, 3871045, 3877666, 3884240, 3887744, 3894868, 3901292, 3907986, 3920936, 3923717, 3931141, 3939634, 3942458, 3942459, 3942460, 3949039, 3955799, 3955800, 3955801, 3962597, 3982681, 3982682, 3988103, 3988104, 3988105, 3988106, 3991169, 3991170, 3991171, 3991172, 4015552, 4015553, 4015556, 4015557, 4018520, 4033726, 4035745, 4051624, 4053731, 4060211, 4071980, 4083912, 4093737, 4105258, 4107600, 4113105, 4122436, 4136141, 4148002, 4156616, 4163820, 4179359, 4185424, 4196280, 4197617, 4209568, 4212781, 4216325, 4217445, 4223731, 4231504, 4237386, 4240152, 4254249, 4276466, 4279335, 4283242, 4289483, 4289484, 4292172, 4322676, 4335015, 4335016, 4345015, 4347208, 4351241, 4353064, 4353095, 4374444, 4374445, 4374446, 4379941, 4381022, 4383633, 4383634, 4388176, 4388177, 4388178, 4388179, 4389903, 4395789;  f) UDI/DI 15021312005882, Product Code/List Number/Item Code 60PFS50, Lot Numbers:  3840085, 3868297, 3868298, 3868299, 3877642, 3884250, 3894889, 3897872, 3911431, 3920969, 3939629, 3942455, 3946245, 3949028, 3955787, 3955788, 3962600, 3982684, 3988108, 3988109, 3988110, 3991174, 3991175, 3991176, 3997817, 3997828, 4015558, 4018521, 4018522, 4029511, 4051631, 4060227, 4071969, 4083931, 4096826, 4100896, 4110455, 4122443, 4128043, 4145694, 4153587, 4159976, 4168142, 4171553, 4180498, 4204819, 4206821, 4212782, 4217446, 4218709, 4221347, 4233968, 4254252, 4279336, 4283243, 4286805, 4289485, 4292173, 4335017, 4335018, 4345016, 4345017, 4352788, 4365778, 4366203, 4369601, 4369602, 4374447, 4374448, 4381023, 4383635, 4388180, 4388181, 4389904, 4395790, 4399191;  g) UDI/DI 15021312005899, Product Code/List Number/Item Code 60PFS55, Lot Numbers:  3853464, 3868208, 3868209, 3877656, 3877657, 3884235, 3901309, 3911422, 3930034, 3930035, 3930036, 3930037, 3936573, 3939625, 3950394, 3982685, 3988111, 3988112, 3991177, 3991178, 3991179, 3997818, 3997829, 4033727, 4035746, 4053735, 4063188, 4083938, 4105250, 4110456, 4122426, 4128035, 4148016, 4163837, 4179360, 4180173, 4204820, 4209569, 4233969, 4276467, 4283244, 4289486, 4322677, 4335020, 4335021, 4352789, 4362868, 4369603, 4369604, 4374449, 4383636, 4388182, 4389905, 4395791, 4399192. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2599-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2599-2024&lang=eng"
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2599-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2599-2024 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
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "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-2599-2024&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-2599-2024&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-2599-2024/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
      },
      "grounding": {
        "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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      "name": "FDA recall details — Z-2599-2024",
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            "Value": "Class I",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "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.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers:   3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474;  b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers:  3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668;  c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers:  3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702, 3884241, 3887745, 3891532, 3901293, 3904667, 3907987, 3917981, 3920937, 3920938, 3930041, 3936575, 3942465, 3942466, 3942467, 3942468, 3946228, 3946229, 3946230, 3946231, 3955802, 3962598, 3962599, 3982671, 3982672, 3988094, 3988095, 3988096, 3988097, 3991159, 3991160, 3991161, 3991162, 4005651, 4005654, 4008218, 4008219, 4015546, 4015547, 4021418, 4026694, 4033724, 4035743, 4048010, 4051625, 4053720, 4056230, 4060212, 4060213, 4063185, 4071981, 4075241, 4083914, 4089301, 4092633, 4097833, 4105259, 4107594, 4110454, 4116094, 4122438, 4128018, 4130990, 4134027, 4145710, 4148001, 4151036, 4153618, 4156615, 4159944, 4163822, 4163823, 4176221, 4179357, 4185420, 4196279, 4197615, 4201384, 4204817, 4206819, 4209565, 4216323, 4217444, 4218707, 4221345, 4223730, 4231501, 4233963, 4233964, 4240150, 4254247, 4260068, 4273426, 4279333, 4283240, 4286802, 4289480, 4292167, 4292168, 4331613, 4331614, 4335008, 4335009, 4335010, 4335011, 4345012, 4352785, 4352786, 4360406, 4360407, 4360408, 4369596, 4369598, 4374441, 4374442, 4374443, 4381018, 4381019, 4381020, 4383627, 4383628, 4383632, 4388169, 4388170, 4388171, 4388172, 4393410;  d) UDI/DI 15021312005868, Product Code/List Number/Item Code 60PFS40, Lot Numbers:  3835740, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3871061, 3880721, 3880722, 3884259, 3887731, 3894886, 3894887, 3897887, 3901308, 3907996, 3907997, 3918003, 3920955, 3942503, 3942504, 3942505, 3942506, 3946268, 3946269, 3946270, 3955782, 3955783, 3955784, 3955785, 3959304, 3959305, 3962576, 3982674, 3982679, 3982680, 3982683, 3988100, 3988101, 3988102, 3991164, 3991165, 3991166, 3991167, 3991168, 4005655, 4005656, 4005662, 4005664, 4005665, 4005666, 4015548, 4015549, 4015550, 4033725, 4048022, 4051650, 4051651, 4053718, 4056236, 4056237, 4063186, 4063187, 4071985, 4071986, 4075242, 4077110, 4080791, 4089309, 4093736, 4107572, 4107573, 4113115, 4119101, 4122448, 4128031, 4139013, 4145719, 4151013, 4153596, 4159975, 4161991, 4163834, 4171552, 4176239, 4179358, 4180464, 4185421, 4185422, 4185423, 4204818, 4206820, 4209566, 4209567, 4212780, 4216324, 4218708, 4221346, 4231502, 4233965, 4233967, 4234639, 4237385, 4240151, 4254248, 4260069, 4273427, 4279334, 4283241, 4286803, 4286804, 4289481, 4289482, 4292169, 4292170, 4322675, 4331615, 4335012, 4335013, 4335014, 4345013, 4345014, 4348476, 4348477, 4351240, 4355431, 4355432, 4357235, 4357236, 4357237, 4358510, 4365777, 4369600, 4379950, 4379960, 4381021, 4383629, 4383630, 4383631, 4388173, 4388174, 4388175, 4389901, 4389902, 4399188;  e) UDI/DI 15021312005875, Product Code/List Number/Item Code 60PFS45, Lot Numbers:  3843109, 3853462, 3868224, 3871045, 3877666, 3884240, 3887744, 3894868, 3901292, 3907986, 3920936, 3923717, 3931141, 3939634, 3942458, 3942459, 3942460, 3949039, 3955799, 3955800, 3955801, 3962597, 3982681, 3982682, 3988103, 3988104, 3988105, 3988106, 3991169, 3991170, 3991171, 3991172, 4015552, 4015553, 4015556, 4015557, 4018520, 4033726, 4035745, 4051624, 4053731, 4060211, 4071980, 4083912, 4093737, 4105258, 4107600, 4113105, 4122436, 4136141, 4148002, 4156616, 4163820, 4179359, 4185424, 4196280, 4197617, 4209568, 4212781, 4216325, 4217445, 4223731, 4231504, 4237386, 4240152, 4254249, 4276466, 4279335, 4283242, 4289483, 4289484, 4292172, 4322676, 4335015, 4335016, 4345015, 4347208, 4351241, 4353064, 4353095, 4374444, 4374445, 4374446, 4379941, 4381022, 4383633, 4383634, 4388176, 4388177, 4388178, 4388179, 4389903, 4395789;  f) UDI/DI 15021312005882, Product Code/List Number/Item Code 60PFS50, Lot Numbers:  3840085, 3868297, 3868298, 3868299, 3877642, 3884250, 3894889, 3897872, 3911431, 3920969, 3939629, 3942455, 3946245, 3949028, 3955787, 3955788, 3962600, 3982684, 3988108, 3988109, 3988110, 3991174, 3991175, 3991176, 3997817, 3997828, 4015558, 4018521, 4018522, 4029511, 4051631, 4060227, 4071969, 4083931, 4096826, 4100896, 4110455, 4122443, 4128043, 4145694, 4153587, 4159976, 4168142, 4171553, 4180498, 4204819, 4206821, 4212782, 4217446, 4218709, 4221347, 4233968, 4254252, 4279336, 4283243, 4286805, 4289485, 4292173, 4335017, 4335018, 4345016, 4345017, 4352788, 4365778, 4366203, 4369601, 4369602, 4374447, 4374448, 4381023, 4383635, 4388180, 4388181, 4389904, 4395790, 4399191;  g) UDI/DI 15021312005899, Product Code/List Number/Item Code 60PFS55, Lot Numbers:  3853464, 3868208, 3868209, 3877656, 3877657, 3884235, 3901309, 3911422, 3930034, 3930035, 3930036, 3930037, 3936573, 3939625, 3950394, 3982685, 3988111, 3988112, 3991177, 3991178, 3991179, 3997818, 3997829, 4033727, 4035746, 4053735, 4063188, 4083938, 4105250, 4110456, 4122426, 4128035, 4148016, 4163837, 4179360, 4180173, 4204820, 4209569, 4233969, 4276467, 4283244, 4289486, 4322677, 4335020, 4335021, 4352789, 4362868, 4369603, 4369604, 4374449, 4383636, 4388182, 4389905, 4395791, 4399192",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}