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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2025.jsonld",
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  "name": "Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B",
  "description": "FDA recall Z-1591-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B (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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    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B",
    "manufacturer": {
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1591-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B",
      "text": "The FDA logged enforcement record Z-1591-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits used for various procedures:  1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A;   3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B;   5) CATH PACK, Model Number: DYNJ51338C;   6) BRISTOL MYELOGRAM, Model Number: DYNDH1228;   7) CARDIAC CATH-LEFT HEART, Model Number: DYNJ83961A;   8) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G;   9) CATH LAB PACK, Model Number: DYNJ85070;   10) CT SCAN PACK, Model Number: DYNJ39515A;   11) ANGIOGRAPHY DRAPE PACK, Model Number: 00-398650AJ;   12) I.R. RADIOLOGY PACK, Model Number: DYNJ24812D;   13) (CH) ARTERIOGRAM ADD ON PACK, Model Number: DYNJ69974;   14) BASE HEMODYNAMIE-LF, Model Number: DYNJ69135A;   15) INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ45020;   16) PORTACATH PACK, Model Number: DYNJ51240A;   17) RADIOLOGY PACK, Model Number: DYNJ43969;   18) LEFT HEART SMGH-LF 2, Model Number: DYNJ41932I;   19) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D;   20) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B — reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-03. Affected lots/codes: 1) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24IBS428; 2) DYNJ64354A, UDI-DI: 10195327156312(each), 40195327156313(case), Lot Number: 24JBM450; 3) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24JBM593; 4) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24JBN316; 5) DYNJ51338C, UDI-DI: 10193489241716(each), 40193489241717(case), Lot Number: 24JBN784; 6) DYNDH1228, UDI-DI: 10889942572007(each), 40889942572008(case), Lot Number: 24JBU509; 7) DYNJ83961A, UDI-DI: 10195327517748(each), 40195327517749(case), Lot Number: 24JBW818; 8) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24JBX138; 9) DYNJ85070, UDI-DI: 10195327455392(each), 40195327455393(case), Lot Number: 24JBY293; 10) DYNJ39515A, UDI-DI: 10889942753130(each), 40889942753131(case), Lot Number: 24KBA200; 11) 00-398650AJ, UDI-DI: 10195327330903(each), 40195327330904(case), Lot Number: 24KBA758; 12) DYNJ24812D, UDI-DI: 10884389653210(each), 40884389653211(case), Lot Number: 24KBB397; 13) DYNJ69974, UDI-DI: 10195327001117(each), 40195327001118(case), Lot Number: 24KBB454; 14) DYNJ69135A, UDI-DI: 10195327140496(each), 40195327140497(case), Lot Number: 24KBC186; 15) DYNJ45020, UDI-DI: 10888277086685(each), 40888277086686(case), Lot Number: 24KBC962; 16) DYNJ51240A, UDI-DI: 10889942493524(each), 40889942493525(case), Lot Number: 24KBE652; 17) DYNJ43969, UDI-DI: 10888277077089(each), 40888277077080(case), Lot Number: 24KBF965; 18) DYNJ41932I, UDI-DI: 10198459078699(each), 40198459078690(case), Lot Number: 24KBG499; 19) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24KBG961; 20) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24KBH847. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1591-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-1591-2025&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-1591-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1591-2025 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",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1591-2025&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-1591-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1591-2025/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": {
        "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-1591-2025",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1591-2025",
            "Status": "recorded"
          }
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          "@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"
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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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-03",
            "Status": "recorded"
          }
        },
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24IBS428; 2) DYNJ64354A, UDI-DI: 10195327156312(each), 40195327156313(case), Lot Number: 24JBM450; 3) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24JBM593; 4) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24JBN316; 5) DYNJ51338C, UDI-DI: 10193489241716(each), 40193489241717(case), Lot Number: 24JBN784; 6) DYNDH1228, UDI-DI: 10889942572007(each), 40889942572008(case), Lot Number: 24JBU509; 7) DYNJ83961A, UDI-DI: 10195327517748(each), 40195327517749(case), Lot Number: 24JBW818; 8) HCP075G, UDI-DI: 10198459134456(each), 40198459134457(case), Lot Number: 24JBX138; 9) DYNJ85070, UDI-DI: 10195327455392(each), 40195327455393(case), Lot Number: 24JBY293; 10) DYNJ39515A, UDI-DI: 10889942753130(each), 40889942753131(case), Lot Number: 24KBA200; 11) 00-398650AJ, UDI-DI: 10195327330903(each), 40195327330904(case), Lot Number: 24KBA758; 12) DYNJ24812D, UDI-DI: 10884389653210(each), 40884389653211(case), Lot Number: 24KBB397; 13) DYNJ69974, UDI-DI: 10195327001117(each), 40195327001118(case), Lot Number: 24KBB454; 14) DYNJ69135A, UDI-DI: 10195327140496(each), 40195327140497(case), Lot Number: 24KBC186; 15) DYNJ45020, UDI-DI: 10888277086685(each), 40888277086686(case), Lot Number: 24KBC962; 16) DYNJ51240A, UDI-DI: 10889942493524(each), 40889942493525(case), Lot Number: 24KBE652; 17) DYNJ43969, UDI-DI: 10888277077089(each), 40888277077080(case), Lot Number: 24KBF965; 18) DYNJ41932I, UDI-DI: 10198459078699(each), 40198459078690(case), Lot Number: 24KBG499; 19) 0M-CP01029D, UDI-DI: 10888277858114(each), 40888277858115(case), Lot Number: 24KBG961; 20) DYNJ81454B, UDI-DI: 10198459100109(each), 40198459100100(case), Lot Number: 24KBH847",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}