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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2328-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Presource kits and trays, labeled as:    1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;   2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;   3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11;   4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12;   5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13;   6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14;   8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8;   9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9;   10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG;   11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH;   12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI",
  "description": "FDA recall Z-2328-2024 — Cardinal Health 200, LLC is recalling Presource kits and trays, labeled as:    1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;   2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;   3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11;   4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12;   5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13;   6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14;   8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8;   9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9;   10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG;   11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH;   12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI (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.",
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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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      "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-2328-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Presource kits and trays, labeled as:    1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;   2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;   3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11;   4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12;   5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13;   6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14;   8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8;   9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9;   10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG;   11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH;   12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2328-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2328-2024: Cardinal Health 200, LLC is recalling Presource kits and trays, labeled as:    1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;   2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;   3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11;   4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12;   5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13;   6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14;   8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8;   9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9;   10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG;   11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH;   12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI",
      "text": "The FDA logged enforcement record Z-2328-2024: Cardinal Health 200, LLC is voluntarily recalling Presource kits and trays, labeled as:    1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB;   2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10;   3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11;   4) Cardiac Catheterization Kit, Catalog Number SAN73CCV12;   5) Cardiac Catheterization Kit, Catalog Number SAN73CCV13;   6) Cardiac Catheterization Kit, Catalog Number SAN73CCV14;   8) Cardiac Catheterization Kit, Catalog Number SAN73CCVD8;   9) Cardiac Catheterization Kit, Catalog Number SAN73CCVD9;   10) Cardiac Catheterization Kit, Catalog Number SAN73CCVDG;   11) Cardiac Catheterization Kit, Catalog Number SAN73CCVDH;   12) Cardiac Catheterization Kit, Catalog Number SAN73CCVDI — reason: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-29. Affected lots/codes: 1) SAN69CCKRB, UDI/DI (CS/EA) 50195594062079/10195594062071, Lot Numbers:  205373;  2) SAN73CCV10, UDI/DI (CS/EA) 50195594753557/10195594753559, Lot Numbers:  870093;  3) SAN73CCV11, UDI/DI (CS/EA) 50195594870773/10195594870775, Lot Numbers:  915202;  4) SAN73CCV12, UDI/DI (CS/EA) 50197106021987/10197106021989, Lot Numbers:  934300;  5) SAN73CCV13, UDI/DI (CS/EA) 50197106371433/10197106371435, Lot Numbers:  86630;  6) SAN73CCV14, UDI/DI (CS/EA) 50197106559763/10197106559765, Lot Numbers:  209283;  8) SAN73CCVD8, UDI/DI (CS/EA) 50195594589613/10195594589615, Lot Numbers:  791638;  9) SAN73CCVD9, UDI/DI (CS/EA) 50195594615961/10195594615963, Lot Numbers:  803098;  10) SAN73CCVDG, UDI/DI (CS/EA) 50195594546531/10195594546533, Lot Numbers:  29048, 52931, 69859, 821471, 843529, 890800, 951235, 980133, 998592;  11) SAN73CCVDH, UDI/DI (CS/EA) 50197106375516/10197106375518, Lot Numbers:  106841, 149021, 227027, 258282;  12) SAN73CCVDI, UDI/DI (CS/EA) 50197106642007/10197106642009, Lot Numbers:  265079. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-2328-2024&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-2328-2024&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-2328-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2328-2024 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
      },
      "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-2328-2024&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-2328-2024&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-2328-2024/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,
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      "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-2328-2024",
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            "Value": "Z-2328-2024",
            "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 II",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-29",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) SAN69CCKRB, UDI/DI (CS/EA) 50195594062079/10195594062071, Lot Numbers:  205373;  2) SAN73CCV10, UDI/DI (CS/EA) 50195594753557/10195594753559, Lot Numbers:  870093;  3) SAN73CCV11, UDI/DI (CS/EA) 50195594870773/10195594870775, Lot Numbers:  915202;  4) SAN73CCV12, UDI/DI (CS/EA) 50197106021987/10197106021989, Lot Numbers:  934300;  5) SAN73CCV13, UDI/DI (CS/EA) 50197106371433/10197106371435, Lot Numbers:  86630;  6) SAN73CCV14, UDI/DI (CS/EA) 50197106559763/10197106559765, Lot Numbers:  209283;  8) SAN73CCVD8, UDI/DI (CS/EA) 50195594589613/10195594589615, Lot Numbers:  791638;  9) SAN73CCVD9, UDI/DI (CS/EA) 50195594615961/10195594615963, Lot Numbers:  803098;  10) SAN73CCVDG, UDI/DI (CS/EA) 50195594546531/10195594546533, Lot Numbers:  29048, 52931, 69859, 821471, 843529, 890800, 951235, 980133, 998592;  11) SAN73CCVDH, UDI/DI (CS/EA) 50197106375516/10197106375518, Lot Numbers:  106841, 149021, 227027, 258282;  12) SAN73CCVDI, UDI/DI (CS/EA) 50197106642007/10197106642009, Lot Numbers:  265079",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Nationwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}