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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1801-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medtronic Cardioplegia Adapters:    a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,   b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,   c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,   d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,   e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,   f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,   g) DLP¿  Y  Adapter   Coronary Perfusion, Model Number 10710",
  "description": "FDA recall Z-1801-2024 — Medtronic Perfusion Systems is recalling Medtronic Cardioplegia Adapters:    a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,   b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,   c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,   d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,   e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,   f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,   g) DLP¿  Y  Adapter   Coronary Perfusion, Model Number 10710 (Devices, Class II). 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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1801-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medtronic Cardioplegia Adapters:    a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,   b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,   c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,   d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,   e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,   f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,   g) DLP¿  Y  Adapter   Coronary Perfusion, Model Number 10710",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medtronic Perfusion Systems"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1801-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1801-2024: Medtronic Perfusion Systems is recalling Medtronic Cardioplegia Adapters:    a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,   b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,   c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,   d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,   e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,   f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,   g) DLP¿  Y  Adapter   Coronary Perfusion, Model Number 10710",
      "text": "The FDA logged enforcement record Z-1801-2024: Medtronic Perfusion Systems is voluntarily recalling Medtronic Cardioplegia Adapters:    a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,   b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010,   c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,   d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000,   e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G,   f) DLP¿ Perfusion/Venting Adapter, Model Number 13002,   g) DLP¿  Y  Adapter   Coronary Perfusion, Model Number 10710 — reason: Potential for unsealed sterile packing.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-19. Affected lots/codes: a) Model Number 25009, GTIN 20613994918608, Lot Numbers:  2023040212, 202305C110;   b) Model Number 25010, GTIN 20613994918585, Lot Numbers:  2023041227, 202305C111;   c) Model Number 14003, GTIN 00613994619662, Lot Numbers:  2023040464;   c)  Model Number 14003, GTIN 20613994619666, Lot Numbers:  2023040463, 2023040464, 202305C102;   d) Model Number 14000, GTIN 00613994619716, Lot Numbers:  2023041205, 2023041206;   d) Model Number 14000, GTIN 20613994619710, Lot Numbers:  2023041205, 2023041206, 202305C098, 202305C099;   e) Model Number 11001G, GTIN 00613994918550, Lot Numbers:  2023031005;   e) Model Number 11001G, GTIN 20613994918554, Lot Numbers:  2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218;   f) Model Number 13002, GTIN 20613994756057, Lot Numbers:  2023040459, 202305C097;   g) Model Number 10710, GTIN 20613994685937, Lot Numbers:  20613994685937. 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": {
        "groundingType": "SourceCitation",
        "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-1801-2024&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-1801-2024&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-1801-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1801-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. 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": {
        "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-1801-2024&lang=eng",
        "value": "Class II",
        "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-1801-2024&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-1801-2024/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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1801-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1801-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic Perfusion Systems",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for unsealed sterile packing.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-03-19",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) Model Number 25009, GTIN 20613994918608, Lot Numbers:  2023040212, 202305C110;   b) Model Number 25010, GTIN 20613994918585, Lot Numbers:  2023041227, 202305C111;   c) Model Number 14003, GTIN 00613994619662, Lot Numbers:  2023040464;   c)  Model Number 14003, GTIN 20613994619666, Lot Numbers:  2023040463, 2023040464, 202305C102;   d) Model Number 14000, GTIN 00613994619716, Lot Numbers:  2023041205, 2023041206;   d) Model Number 14000, GTIN 20613994619710, Lot Numbers:  2023041205, 2023041206, 202305C098, 202305C099;   e) Model Number 11001G, GTIN 00613994918550, Lot Numbers:  2023031005;   e) Model Number 11001G, GTIN 20613994918554, Lot Numbers:  2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218;   f) Model Number 13002, GTIN 20613994756057, Lot Numbers:  2023040459, 202305C097;   g) Model Number 10710, GTIN 20613994685937, Lot Numbers:  20613994685937",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}