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  "name": "CADD Solis VIP Ambulatory Infusion Pump Models:    1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL  MODE, 1/EA, Model Number: 21-2127-0105-01;     2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED, 1/EA, Model Number: 21-2120-0105-01;     3) PUMP KIT, CADD-SOLIS VIP, MDL  2120, NA ENGLISH     1/EA, Model Number: 21-2120-0103-01;     4) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;     5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED    1/EA, Model Number: 21-2120-0104-01;     6) PUMP KIT, CADD-SOLIS VIP, MDL  2120, CE GLOBAL ENGLISH     1/EA, Model Number: 21-2120-0103-51;    7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE     1/EA, Model Number: 21-2127-0104-01;   8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;    9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL  ENGLISH    1/EA, Model Number: 21-2120-0103-78;     10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER  1/EA, Model Number: 21-2120-0102-78;     11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,  PHARMGUARD ENABLED    1/EA, Model Number: 21-2120-0104-231;     12) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249;     13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH  1/EA, Model Number: 21-2120-0103-249;    14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY      1/EA, Model Number: 21-2125-0104-01;    15) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249.",
  "description": "FDA recall Z-1682-2025 — Smiths Medical ASD, Inc. is recalling CADD Solis VIP Ambulatory Infusion Pump Models:    1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL  MODE, 1/EA, Model Number: 21-2127-0105-01;     2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED, 1/EA, Model Number: 21-2120-0105-01;     3) PUMP KIT, CADD-SOLIS VIP, MDL  2120, NA ENGLISH     1/EA, Model Number: 21-2120-0103-01;     4) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;     5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED    1/EA, Model Number: 21-2120-0104-01;     6) PUMP KIT, CADD-SOLIS VIP, MDL  2120, CE GLOBAL ENGLISH     1/EA, Model Number: 21-2120-0103-51;    7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE     1/EA, Model Number: 21-2127-0104-01;   8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;    9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL  ENGLISH    1/EA, Model Number: 21-2120-0103-78;     10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER  1/EA, Model Number: 21-2120-0102-78;     11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,  PHARMGUARD ENABLED    1/EA, Model Number: 21-2120-0104-231;     12) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249;     13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH  1/EA, Model Number: 21-2120-0103-249;    14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY      1/EA, Model Number: 21-2125-0104-01;    15) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249. (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": "CADD Solis VIP Ambulatory Infusion Pump Models:    1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL  MODE, 1/EA, Model Number: 21-2127-0105-01;     2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED, 1/EA, Model Number: 21-2120-0105-01;     3) PUMP KIT, CADD-SOLIS VIP, MDL  2120, NA ENGLISH     1/EA, Model Number: 21-2120-0103-01;     4) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;     5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED    1/EA, Model Number: 21-2120-0104-01;     6) PUMP KIT, CADD-SOLIS VIP, MDL  2120, CE GLOBAL ENGLISH     1/EA, Model Number: 21-2120-0103-51;    7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE     1/EA, Model Number: 21-2127-0104-01;   8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;    9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL  ENGLISH    1/EA, Model Number: 21-2120-0103-78;     10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER  1/EA, Model Number: 21-2120-0102-78;     11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,  PHARMGUARD ENABLED    1/EA, Model Number: 21-2120-0104-231;     12) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249;     13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH  1/EA, Model Number: 21-2120-0103-249;    14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY      1/EA, Model Number: 21-2125-0104-01;    15) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249.",
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1682-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1682-2025: Smiths Medical ASD, Inc. is recalling CADD Solis VIP Ambulatory Infusion Pump Models:    1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL  MODE, 1/EA, Model Number: 21-2127-0105-01;     2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED, 1/EA, Model Number: 21-2120-0105-01;     3) PUMP KIT, CADD-SOLIS VIP, MDL  2120, NA ENGLISH     1/EA, Model Number: 21-2120-0103-01;     4) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;     5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED    1/EA, Model Number: 21-2120-0104-01;     6) PUMP KIT, CADD-SOLIS VIP, MDL  2120, CE GLOBAL ENGLISH     1/EA, Model Number: 21-2120-0103-51;    7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE     1/EA, Model Number: 21-2127-0104-01;   8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;    9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL  ENGLISH    1/EA, Model Number: 21-2120-0103-78;     10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER  1/EA, Model Number: 21-2120-0102-78;     11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,  PHARMGUARD ENABLED    1/EA, Model Number: 21-2120-0104-231;     12) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249;     13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH  1/EA, Model Number: 21-2120-0103-249;    14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY      1/EA, Model Number: 21-2125-0104-01;    15) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249.",
      "text": "The FDA logged enforcement record Z-1682-2025: Smiths Medical ASD, Inc. is voluntarily recalling CADD Solis VIP Ambulatory Infusion Pump Models:    1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL  MODE, 1/EA, Model Number: 21-2127-0105-01;     2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED, 1/EA, Model Number: 21-2120-0105-01;     3) PUMP KIT, CADD-SOLIS VIP, MDL  2120, NA ENGLISH     1/EA, Model Number: 21-2120-0103-01;     4) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51;     5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD  ENABLED    1/EA, Model Number: 21-2120-0104-01;     6) PUMP KIT, CADD-SOLIS VIP, MDL  2120, CE GLOBAL ENGLISH     1/EA, Model Number: 21-2120-0103-51;    7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE     1/EA, Model Number: 21-2127-0104-01;   8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00;    9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL  ENGLISH    1/EA, Model Number: 21-2120-0103-78;     10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER  1/EA, Model Number: 21-2120-0102-78;     11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH,  PHARMGUARD ENABLED    1/EA, Model Number: 21-2120-0104-231;     12) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249;     13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH  1/EA, Model Number: 21-2120-0103-249;    14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY      1/EA, Model Number: 21-2125-0104-01;    15) PUMP, CADD-SOLIS VIP, MDL  2120, ENGLISH, NFHU  1/EA, Model Number: 21-2120-0102-249. — reason: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-10. Affected lots/codes: All serial numbers.   1 )  21-2127-0105-01 ,  UDI-DI:  15019517150292 ; 2 )  21-2120-0105-01 ,  UDI-DI:  15019517150001 ; 3 )  21-2120-0103-01 ,  UDI-DI:  15019517084368 ; 4 )  21-2120-0102-51 ,  UDI-DI:  10610586042829 ; 5 )  21-2120-0104-01 ,  UDI-DI:  15019517126587 ; 6 )  21-2120-0103-51 ,  UDI-DI:  15019517096378 ; 7 )  21-2127-0104-01 ,  UDI-DI:  15019517126600 ; 8 )  21-2120-0105-00 ,  UDI-DI:  15019517149999 ; 9 )  21-2120-0103-78 ,  UDI-DI:  15019517096392 ; 10 )  21-2120-0102-78 ,  UDI-DI:  10610586042836 ; 11 )  21-2120-0104-231 ,  UDI-DI:  15019517126617 ; 12 )  21-2120-0102-249 ,  UDI-DI:  10610586042843 ; 13 )  21-2120-0103-249 ,  UDI-DI:  15019517096385 ; 14 )  21-2125-0104-01 ,  UDI-DI:  15019517126594 ; 15 )  21-2120-0102-249 ,  UDI-DI:  10610586042843 ;. 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-1682-2025&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-1682-2025&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-1682-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1682-2025 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",
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        "occurred": false,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1682-2025&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1682-2025/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": {
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      "grounding": {
        "groundingType": "Interpretation",
        "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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            "Status": "recorded"
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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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD, Inc.",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-04-10",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All serial numbers.   1 )  21-2127-0105-01 ,  UDI-DI:  15019517150292 ; 2 )  21-2120-0105-01 ,  UDI-DI:  15019517150001 ; 3 )  21-2120-0103-01 ,  UDI-DI:  15019517084368 ; 4 )  21-2120-0102-51 ,  UDI-DI:  10610586042829 ; 5 )  21-2120-0104-01 ,  UDI-DI:  15019517126587 ; 6 )  21-2120-0103-51 ,  UDI-DI:  15019517096378 ; 7 )  21-2127-0104-01 ,  UDI-DI:  15019517126600 ; 8 )  21-2120-0105-00 ,  UDI-DI:  15019517149999 ; 9 )  21-2120-0103-78 ,  UDI-DI:  15019517096392 ; 10 )  21-2120-0102-78 ,  UDI-DI:  10610586042836 ; 11 )  21-2120-0104-231 ,  UDI-DI:  15019517126617 ; 12 )  21-2120-0102-249 ,  UDI-DI:  10610586042843 ; 13 )  21-2120-0103-249 ,  UDI-DI:  15019517096385 ; 14 )  21-2125-0104-01 ,  UDI-DI:  15019517126594 ; 15 )  21-2120-0102-249 ,  UDI-DI:  10610586042843 ;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
          }
        }
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}