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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2444-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline procedure kits labeled as:    1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;   2) VASCULAR PACK , Pack Number CMPJ11455B ;   3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;   4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ;   5) ARTERIOGRAM PACK, Pack Number DYNJ53018;   6) CATH PACK , Pack Number DYNJ57729C ;   7) PEDS CATH PACK, Pack Number DYNJ66856;   8) PEDS CATH PACK, Pack Number DYNJ66856A ;   9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ;   10) CATH LAB PACK , Pack Number DYNJ84617;   11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A",
  "description": "FDA recall Z-2444-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:    1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;   2) VASCULAR PACK , Pack Number CMPJ11455B ;   3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;   4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ;   5) ARTERIOGRAM PACK, Pack Number DYNJ53018;   6) CATH PACK , Pack Number DYNJ57729C ;   7) PEDS CATH PACK, Pack Number DYNJ66856;   8) PEDS CATH PACK, Pack Number DYNJ66856A ;   9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ;   10) CATH LAB PACK , Pack Number DYNJ84617;   11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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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-2444-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline procedure kits labeled as:    1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;   2) VASCULAR PACK , Pack Number CMPJ11455B ;   3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;   4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ;   5) ARTERIOGRAM PACK, Pack Number DYNJ53018;   6) CATH PACK , Pack Number DYNJ57729C ;   7) PEDS CATH PACK, Pack Number DYNJ66856;   8) PEDS CATH PACK, Pack Number DYNJ66856A ;   9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ;   10) CATH LAB PACK , Pack Number DYNJ84617;   11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2444-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2444-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline procedure kits labeled as:    1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;   2) VASCULAR PACK , Pack Number CMPJ11455B ;   3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;   4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ;   5) ARTERIOGRAM PACK, Pack Number DYNJ53018;   6) CATH PACK , Pack Number DYNJ57729C ;   7) PEDS CATH PACK, Pack Number DYNJ66856;   8) PEDS CATH PACK, Pack Number DYNJ66856A ;   9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ;   10) CATH LAB PACK , Pack Number DYNJ84617;   11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A",
      "text": "The FDA logged enforcement record Z-2444-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline procedure kits labeled as:    1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ;   2) VASCULAR PACK , Pack Number CMPJ11455B ;   3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ;   4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ;   5) ARTERIOGRAM PACK, Pack Number DYNJ53018;   6) CATH PACK , Pack Number DYNJ57729C ;   7) PEDS CATH PACK, Pack Number DYNJ66856;   8) PEDS CATH PACK, Pack Number DYNJ66856A ;   9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ;   10) CATH LAB PACK , Pack Number DYNJ84617;   11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: CMPJ08068F , Lot Number 24ABN950 ;  CMPJ11455B , Lot Number 23IBD357 ;  DYNJ26938J , Lot Number 22FBD709 ;  DYNJ26938J , Lot Number 22GBH459 ;  DYNJ26938J , Lot Number 22HBR225 ;  DYNJ26938J , Lot Number 22IBJ562 ;  DYNJ26938J , Lot Number 22JBP469 ;  DYNJ26938J , Lot Number 23ABM365 ;  DYNJ26938J , Lot Number 23CBM109 ;  DYNJ26938J , Lot Number 23DBN340 ;  DYNJ26938J , Lot Number 23GBH016 ;  DYNJ26938J , Lot Number 23IBS867 ;  DYNJ53018, Lot Number 21IBX266 ;  DYNJ53018, Lot Number 22GBN555 ;  DYNJ53018, Lot Number 23ABN207 ;  DYNJ57729C , Lot Number 23HBK882 ;  DYNJ57729C , Lot Number 24ABO025 ;  DYNJ66856, Lot Number 21KBH003 ;  DYNJ66856A , Lot Number 22DBD158 ;  DYNJ66856A , Lot Number 22FBY433 ;  DYNJ66856A , Lot Number 22GBK576 ;  DYNJ66856A , Lot Number 22HBQ139 ;  DYNJ66856A , Lot Number 22IBO303 ;  DYNJ66856A , Lot Number 22JBO861 ;  DYNJ66856A , Lot Number 22JBQ914 ;  DYNJ66856A , Lot Number 23ABT952 ;  DYNJ66856A , Lot Number 23CBF157 ;  DYNJ66856A , Lot Number 23EBE461 ;  DYNJ66856A , Lot Number 23EBI477 ;  DYNJ66856A , Lot Number 23HBD973 ;  DYNJ81061A , Lot Number 23HBN396 ;  DYNJ84617, Lot Number 23FBR368 ;  DYNJ49920L , Lot Number 23KMB066 ;  UVT1190A , Lot Number 23BLA187 ;  UVT1190A , Lot Number 23DLA246 ;  UVT1190A , Lot Number 23KLA117 ;  UVT1190A , Lot Number 23LLA329. 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-2444-2024&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-2444-2024&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-2444-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2444-2024 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",
      "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-2444-2024&lang=eng",
        "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-2444-2024&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-2444-2024/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
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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-2444-2024",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2444-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
          }
        },
        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "CMPJ08068F , Lot Number 24ABN950 ;  CMPJ11455B , Lot Number 23IBD357 ;  DYNJ26938J , Lot Number 22FBD709 ;  DYNJ26938J , Lot Number 22GBH459 ;  DYNJ26938J , Lot Number 22HBR225 ;  DYNJ26938J , Lot Number 22IBJ562 ;  DYNJ26938J , Lot Number 22JBP469 ;  DYNJ26938J , Lot Number 23ABM365 ;  DYNJ26938J , Lot Number 23CBM109 ;  DYNJ26938J , Lot Number 23DBN340 ;  DYNJ26938J , Lot Number 23GBH016 ;  DYNJ26938J , Lot Number 23IBS867 ;  DYNJ53018, Lot Number 21IBX266 ;  DYNJ53018, Lot Number 22GBN555 ;  DYNJ53018, Lot Number 23ABN207 ;  DYNJ57729C , Lot Number 23HBK882 ;  DYNJ57729C , Lot Number 24ABO025 ;  DYNJ66856, Lot Number 21KBH003 ;  DYNJ66856A , Lot Number 22DBD158 ;  DYNJ66856A , Lot Number 22FBY433 ;  DYNJ66856A , Lot Number 22GBK576 ;  DYNJ66856A , Lot Number 22HBQ139 ;  DYNJ66856A , Lot Number 22IBO303 ;  DYNJ66856A , Lot Number 22JBO861 ;  DYNJ66856A , Lot Number 22JBQ914 ;  DYNJ66856A , Lot Number 23ABT952 ;  DYNJ66856A , Lot Number 23CBF157 ;  DYNJ66856A , Lot Number 23EBE461 ;  DYNJ66856A , Lot Number 23EBI477 ;  DYNJ66856A , Lot Number 23HBD973 ;  DYNJ81061A , Lot Number 23HBN396 ;  DYNJ84617, Lot Number 23FBR368 ;  DYNJ49920L , Lot Number 23KMB066 ;  UVT1190A , Lot Number 23BLA187 ;  UVT1190A , Lot Number 23DLA246 ;  UVT1190A , Lot Number 23KLA117 ;  UVT1190A , Lot Number 23LLA329",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) and OUS countries of: AE, AI, BB, CA, CL, CY, DE, GT, HN, JP, MX, MY, PA, PE, PR, SA, SG, TC, TT, VI, PR, TT, MX, BM, ES, NI, DO, GU, CR, AT, CD, DE, DF, W, and ON.",
            "Status": "recorded"
          }
        }
      ]
    }
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}