{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0156-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A",
  "description": "FDA recall Z-0156-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0156-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0156-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0156-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A",
      "text": "The FDA logged enforcement record Z-0156-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline brand, medical procedure convenience kits, labeled as:    a) CUH OPEN HEART A B C - CDS, REF CDS983202I;   a) PICC INSERTION KIT, REF DYNDC2486A;   a) OPEN HEART PACK, REF DYNJ01201L;   a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;   a) COTTON ROLL KIT-LF, REF DYNJ32727A;   a) VASCULAR PACK-LF, REF DYNJ32915B;   a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;   a) VALVE ACCESSORY PACK, REF DYNJ36241K;   a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;   a) EP PACK, REF DYNJ40488;   a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;   a) PACEMAKER TEGH-LF, REF DYNJ46745A;   a) VEIN AND LASER PACK, REF DYNJ49874;   a) DR NACKMAN VEIN PACK, REF DYNJ56235;   a) NEUROVASCULAR PACK, REF DYNJ66718A;   a) VEIN TRAY, REF DYNJ69012C;   a) LOOP RECORDER-LF, REF DYNJ69196;   a) U BAR DRAPE, REF DYNJ80064;   a) ENDO, REF DYNJ903814B;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) CARDIAC PROCEDURE, REF DYNJ908126;   a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;   a) VASCULAR EXTREMITY, REF SYNJ910026A — reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-04. Affected lots/codes: a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers:  23LBI662;  b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers:  23LBM830;  c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers:  23LBP126;  d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers:  23LBP442;  e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers:  24ABB296;  f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers:  23LBK382;  g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers:  24ABF463;  h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers:  23LBL339;  i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers:  23LBR317;  j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers:  23LBL628;  k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers:  24ABA421;  l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers:  23KBB860;  m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers:  23LBL699;  n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers:  23EBD843A;  o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers:  24ABN915;  p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers:  23LBQ949;  q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers:  23LBR843;  r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers:  23LBP174;  s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers:  23LBS865;  t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers:  24BBA256;  u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers:  24ABN040;  v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers:  24ABD377;  w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers:  24ABV352. 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-0156-2025&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-0156-2025&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-0156-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0156-2025 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",
      "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-0156-2025&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-0156-2025&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-0156-2025/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,
        "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": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0156-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0156-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-09-04",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers:  23LBI662;  b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers:  23LBM830;  c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers:  23LBP126;  d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers:  23LBP442;  e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers:  24ABB296;  f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers:  23LBK382;  g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers:  24ABF463;  h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers:  23LBL339;  i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers:  23LBR317;  j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers:  23LBL628;  k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers:  24ABA421;  l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers:  23KBB860;  m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers:  23LBL699;  n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers:  23EBD843A;  o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers:  24ABN915;  p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers:  23LBQ949;  q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers:  23LBR843;  r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers:  23LBP174;  s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers:  23LBS865;  t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers:  24BBA256;  u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers:  24ABN040;  v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers:  24ABD377;  w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers:  24ABV352",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}