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  "name": "CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4;  Implantable Cardioverter Defibrillators",
  "description": "FDA recall Z-1731-2023 — Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4;  Implantable Cardioverter Defibrillators (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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    "name": "CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4;  Implantable Cardioverter Defibrillators",
    "manufacturer": {
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      "name": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)"
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      "name": "FDA recall Z-1731-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4;  Implantable Cardioverter Defibrillators",
      "text": "The FDA logged enforcement record Z-1731-2023: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is voluntarily recalling CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4;  Implantable Cardioverter Defibrillators — reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-10. Affected lots/codes: GTIN 00643169720251, Lot Serial Numbers:  BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE221190H, BLE221267H, BLE221842H, BLE221265H, BLE221430H, BLE221711H, BLE221346H, BLE221631H, BLE221285H, BLE221405H, BLE221436H, BLE221551H, BLE221411H, BLE221342H, BLE221584H, BLE221694H, BLE221282H, BLE221465H, BLE221191H, BLE221384H, BLE221805H, BLE221309H, BLE221222H, BLE221327H, BLE221548H, BLE221562H, BLE221702H, BLE221450H, BLE221715H, BLE221246H, BLE221654H, BLE221686H, BLE221713H, BLE221750H, BLE221758H, BLE221814H, BLE221828H, BLE221843H, BLE221844H, BLE221851H, BLE221854H, BLE221855H, BLE221861H, BLE221561H, BLE221727H, BLE221751H, BLE221789H, BLE221862H, BLE221670H, BLE221707H, BLE221752H, BLE221849H, BLE221475H, BLE221687H, BLE221601H, BLE221748H, BLE221173H, BLE221336H, BLE221413H, BLE221426H, BLE221580H, BLE221174H, BLE221176H, BLE221759H, BLE221227H, BLE221660H, BLE221334H, BLE221627H, BLE220376H, BLE221338H, BLE221213H, BLE221349H, 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BLE221858H, BLE221859H, BLE221865H, BLE221595H, BLE221657H, BLE221679H, BLE221307H, BLE221696H, BLE221161H, BLE221162H, BLE221795H, BLE221196H, BLE221640H;  GTIN 00763000059668, Lot Serial Numbers:  BLE600173S, BLE600088S, BLE600188S, BLE600352S, BLE600131S, BLE600302S, BLE600008S, BLE600063S, BLE600238S, BLE600207S, BLE600168S, BLE600107S, BLE600180S, BLE600114S, BLE600111S, BLE600264S, BLE600313S, BLE600360S, BLE600233S, BLE600003S, BLE600191S, BLE600016S, BLE600234S, BLE600059S, BLE600069S, BLE600027S, BLE600071S, BLE600105S, BLE600319S, BLE600139S, BLE600046S, BLE600345S, BLE600006S, BLE600252S, BLE600310S, BLE600151S, BLE600143S, BLE600109S, BLE600297S, BLE600199S, BLE600200S, BLE600393S, BLE600394S, BLE600395S, BLE600396S, BLE600397S, BLE600350S, BLE600011S, BLE600186S, BLE600096S, BLE600037S, BLE600092S, BLE600062S, BLE600202S, BLE600254S, BLE600323S, BLE600240S, BLE600181S, BLE600288S, BLE600311S, BLE600093S, BLE600267S, BLE600380S, BLE600241S, BLE600308S, BLE600125S, BLE600162S, BLE600164S, BLE600208S, BLE600209S, BLE600210S, BLE600332S, BLE600055S, BLE600152S, BLE600089S, BLE600039S, BLE600334S, BLE600392S, BLE600316S, BLE600140S, BLE600044S, BLE600373S, BLE600124S, BLE600176S, BLE600271S, BLE600324S, BLE600354S, BLE600028S, BLE600268S, BLE600371S, BLE600250S, BLE600047S, BLE600386S, BLE600021S, BLE600153S, BLE600237S, BLE600259S, BLE600284S, BLE600299S, BLE600301S, BLE600108S, BLE600388S, BLE600112S, BLE600256S, BLE600337S, BLE600097S, BLE600099S, BLE600138S, BLE600081S, BLE600064S, BLE600041S, BLE600325S, BLE600365S, BLE600183S, BLE600381S, BLE600094S, BLE600189S, BLE600278S, BLE600018S, BLE600012S, BLE600363S, BLE600187S, BLE600351S, BLE600052S, BLE600113S, BLE600129S, BLE600158S, BLE600282S, BLE600362S, BLE600090S, BLE600136S, BLE600281S, BLE600085S, BLE600141S, BLE600073S, BLE600079S, BLE600291S, BLE600225S, BLE600104S, BLE600077S, BLE600231S, BLE600232S, BLE600203S, BLE600119S, BLE600230S, BLE600159S, BLE600204S, BLE600205S, BLE600042S, 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BLE600216S, BLE600315S, BLE600029S, BLE600030S, BLE600031S, BLE600130S. 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-1731-2023&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-1731-2023&lang=eng"
        }
      },
      "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-1731-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1731-2023 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1731-2023&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-1731-2023&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-1731-2023/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-1731-2023",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1731-2023",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "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": "Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)",
            "Status": "recorded"
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        },
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2023-05-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "GTIN 00643169720251, Lot Serial Numbers:  BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE221190H, BLE221267H, BLE221842H, BLE221265H, BLE221430H, BLE221711H, BLE221346H, BLE221631H, BLE221285H, BLE221405H, BLE221436H, BLE221551H, BLE221411H, BLE221342H, BLE221584H, BLE221694H, BLE221282H, BLE221465H, BLE221191H, BLE221384H, BLE221805H, BLE221309H, BLE221222H, BLE221327H, BLE221548H, BLE221562H, BLE221702H, BLE221450H, BLE221715H, BLE221246H, BLE221654H, BLE221686H, BLE221713H, BLE221750H, BLE221758H, BLE221814H, BLE221828H, BLE221843H, BLE221844H, BLE221851H, BLE221854H, BLE221855H, BLE221861H, BLE221561H, BLE221727H, BLE221751H, BLE221789H, BLE221862H, BLE221670H, BLE221707H, BLE221752H, BLE221849H, BLE221475H, BLE221687H, BLE221601H, BLE221748H, BLE221173H, BLE221336H, BLE221413H, BLE221426H, BLE221580H, BLE221174H, BLE221176H, BLE221759H, BLE221227H, BLE221660H, BLE221334H, BLE221627H, BLE220376H, BLE221338H, BLE221213H, BLE221349H, BLE221658H, BLE221661H, BLE221348H, BLE221378H, BLE221423H, BLE221680H, BLE221808H, BLE221542H, BLE221633H, BLE221819H, BLE221863H, BLE221292H, BLE221368H, BLE221492H, BLE221608H, BLE221269H, BLE221700H, BLE221418H, BLE221251H, BLE221761H, BLE221242H, BLE221472H, BLE221473H, BLE221718H, BLE221444H, BLE221662H, BLE221723H, BLE221738H, BLE221746H, BLE221778H, BLE221343H, BLE221823H, BLE221830H, BLE221180H, BLE221262H, BLE221324H, BLE221495H, BLE221505H, BLE221509H, BLE221615H, BLE221622H, BLE221705H, BLE221279H, BLE221295H, BLE221431H, BLE221466H, BLE221674H, BLE221697H, BLE221354H, BLE221310H, BLE221167H, BLE221172H, BLE221564H, BLE221189H, BLE221811H, BLE221178H, BLE221437H, BLE221410H, BLE221373H, BLE221288H, BLE221330H, BLE221537H, BLE221585H, BLE221634H, BLE221655H, BLE221635H, BLE221719H, BLE221721H, BLE221224H, BLE221347H, BLE221381H, BLE221195H, BLE221671H, BLE221199H, BLE221232H, BLE221538H, BLE221731H, BLE221486H, BLE221500H, BLE221248H, BLE221619H, BLE221766H, BLE221179H, BLE221303H, BLE221371H, BLE221539H, BLE221695H, BLE221787H, BLE221760H, BLE221781H, BLE221780H, BLE221522H, BLE221352H, BLE221390H, BLE221238H, BLE221610H, BLE221693H, BLE221163H, BLE221296H, BLE221302H, BLE221400H, BLE221441H, BLE221529H, BLE221588H, BLE221620H, BLE221623H, BLE221630H, BLE221691H, BLE221714H, BLE221730H, BLE221762H, BLE221790H, BLE221799H, BLE221446H, BLE221572H, BLE221643H, BLE221754H, BLE221792H, BLE221846H, BLE221250H, BLE221247H, BLE221648H, BLE221533H, BLE221194H, BLE221318H, BLE221800H, BLE221245H, BLE221313H, BLE221420H, BLE221621H, BLE221625H, BLE221642H, BLE221646H, BLE221650H, BLE221672H, BLE221712H, BLE221753H, BLE221818H, BLE221838H, BLE221520H, BLE221257H, BLE221166H, BLE221626H, BLE221254H, BLE221549H, BLE221553H, BLE221387H, BLE221184H, BLE221488H, BLE221489H, BLE221315H, BLE221263H, BLE221756H, BLE221388H, BLE221421H, BLE221168H, BLE221240H, BLE221209H, BLE220377H, BLE221230H, BLE221667H, BLE221703H, BLE221261H, BLE221299H, BLE221471H, BLE221794H, BLE221841H, BLE221270H, BLE221312H, BLE221374H, BLE221535H, BLE221290H, BLE221329H, BLE221370H, BLE221375H, BLE221406H, BLE221503H, BLE221689H, BLE221802H, BLE221304H, BLE221677H, BLE221220H, BLE221316H, BLE221442H, BLE221339H, BLE221531H, BLE221583H, BLE221221H, BLE221301H, BLE221434H, BLE221788H, BLE221797H, BLE221806H, BLE221366H, BLE221395H, BLE221403H, BLE221528H, BLE221185H, BLE221521H, BLE221809H, BLE221817H, BLE221524H, BLE221228H, BLE221273H, BLE221275H, BLE221332H, BLE221361H, BLE221365H, BLE221394H, BLE221402H, BLE221445H, BLE221526H, BLE221530H, BLE221559H, BLE221573H, BLE221628H, BLE221798H, BLE221484H, BLE221457H, BLE221777H, BLE221786H, BLE221215H, BLE221350H, BLE221801H, BLE221383H, BLE221435H, BLE221653H, BLE221386H, BLE221616H, BLE221664H, BLE221554H, BLE221563H, BLE221735H, BLE221532H, BLE221669H, BLE221379H, BLE221278H, BLE221512H, BLE221467H, BLE221603H, BLE221214H, BLE221207H, BLE221398H, BLE221824H, BLE221793H, BLE221448H, BLE221401H, BLE221681H, BLE221684H, BLE221821H, BLE221576H, BLE221639H, BLE221311H, BLE221636H, BLE221188H, BLE221609H, BLE221659H, BLE221208H, BLE221298H, BLE221359H, BLE221568H, BLE221663H, BLE221675H, BLE221419H, BLE221560H, BLE221216H, BLE221239H, BLE221293H, BLE221358H, BLE221816H, BLE220378H, BLE221233H, BLE221237H, BLE221268H, BLE221276H, BLE221305H, BLE221483H, BLE221491H, BLE221504H, BLE221511H, BLE221613H, BLE221618H, BLE221632H, BLE221692H, BLE221732H, BLE221742H, BLE221749H, BLE221784H, BLE221685H, BLE221360H, BLE221717H, BLE221165H, BLE221236H, BLE221690H, BLE221399H, BLE221253H, BLE221704H, BLE221428H, BLE221219H, BLE221647H, BLE221574H, BLE221326H, BLE221820H, BLE221807H, BLE221864H, BLE221740H, BLE221229H, BLE221259H, BLE221260H, BLE221344H, BLE221369H, BLE221391H, BLE221392H, BLE221393H, BLE221414H, BLE221453H, BLE221589H, BLE221592H, BLE221612H, BLE221614H, BLE221649H, BLE221678H, BLE221698H, BLE221709H, BLE221710H, BLE221737H, BLE221825H, BLE221834H, BLE221850H, BLE221852H, BLE221856H, BLE221857H, BLE221858H, BLE221859H, BLE221865H, BLE221595H, BLE221657H, BLE221679H, BLE221307H, BLE221696H, BLE221161H, BLE221162H, BLE221795H, BLE221196H, BLE221640H;  GTIN 00763000059668, Lot Serial Numbers:  BLE600173S, BLE600088S, BLE600188S, BLE600352S, BLE600131S, BLE600302S, BLE600008S, BLE600063S, BLE600238S, BLE600207S, BLE600168S, BLE600107S, BLE600180S, BLE600114S, BLE600111S, BLE600264S, BLE600313S, BLE600360S, BLE600233S, BLE600003S, BLE600191S, BLE600016S, BLE600234S, BLE600059S, BLE600069S, BLE600027S, BLE600071S, BLE600105S, BLE600319S, BLE600139S, BLE600046S, BLE600345S, BLE600006S, BLE600252S, BLE600310S, BLE600151S, BLE600143S, BLE600109S, BLE600297S, BLE600199S, BLE600200S, BLE600393S, BLE600394S, BLE600395S, BLE600396S, BLE600397S, BLE600350S, BLE600011S, BLE600186S, BLE600096S, BLE600037S, BLE600092S, BLE600062S, BLE600202S, BLE600254S, BLE600323S, BLE600240S, BLE600181S, BLE600288S, BLE600311S, BLE600093S, BLE600267S, BLE600380S, BLE600241S, BLE600308S, BLE600125S, BLE600162S, BLE600164S, BLE600208S, BLE600209S, BLE600210S, BLE600332S, BLE600055S, BLE600152S, BLE600089S, BLE600039S, BLE600334S, BLE600392S, BLE600316S, BLE600140S, BLE600044S, BLE600373S, BLE600124S, BLE600176S, BLE600271S, BLE600324S, BLE600354S, BLE600028S, BLE600268S, BLE600371S, BLE600250S, BLE600047S, BLE600386S, BLE600021S, BLE600153S, BLE600237S, BLE600259S, BLE600284S, BLE600299S, BLE600301S, BLE600108S, BLE600388S, BLE600112S, BLE600256S, BLE600337S, BLE600097S, BLE600099S, BLE600138S, BLE600081S, BLE600064S, BLE600041S, BLE600325S, BLE600365S, BLE600183S, BLE600381S, BLE600094S, BLE600189S, BLE600278S, BLE600018S, BLE600012S, BLE600363S, BLE600187S, BLE600351S, BLE600052S, BLE600113S, BLE600129S, BLE600158S, BLE600282S, BLE600362S, BLE600090S, BLE600136S, BLE600281S, BLE600085S, BLE600141S, BLE600073S, BLE600079S, BLE600291S, BLE600225S, BLE600104S, BLE600077S, BLE600231S, BLE600232S, BLE600203S, BLE600119S, BLE600230S, BLE600159S, BLE600204S, BLE600205S, BLE600042S, BLE600068S, BLE600342S, BLE600169S, BLE600167S, BLE600075S, BLE600344S, BLE600057S, BLE600379S, BLE600382S, BLE600036S, BLE600211S, BLE600213S, BLE600214S, BLE600215S, BLE600066S, BLE600082S, BLE600026S, BLE600370S, BLE600326S, BLE600076S, BLE600193S, BLE600198S, BLE600118S, BLE600314S, BLE600244S, BLE600033S, BLE600377S, BLE600318S, BLE600321S, BLE600387S, BLE600084S, BLE600227S, BLE600253S, BLE600270S, BLE600276S, BLE600298S, BLE600010S, BLE600338S, BLE600013S, BLE600098S, BLE600255S, BLE600289S, BLE600023S, BLE600102S, BLE600147S, BLE600032S, BLE600341S, BLE600391S, BLE600051S, BLE600053S, BLE600343S, BLE600070S, BLE600235S, BLE600274S, BLE600133S, BLE600317S, BLE600194S, BLE600197S, BLE600025S, BLE600266S, BLE600022S, BLE600185S, BLE600346S, BLE600260S, BLE600045S, BLE600339S, BLE600020S, BLE600327S, BLE600286S, BLE600336S, BLE600074S, BLE600132S, BLE600014S, BLE600201S, BLE600261S, BLE600217S, BLE600218S, BLE600219S, BLE600040S, BLE600115S, BLE600126S, BLE600127S, BLE600177S, BLE600216S, BLE600315S, BLE600029S, BLE600030S, BLE600031S, BLE600130S",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide - Worldwide Distribution",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}