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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0778-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline custom medical procedure kits labeled as:    1) OPEN HEART CDS-LF, REFCDS840451M;   2) NEURO PACK, REFDYNJ41516M;   3) RFD- AAA PACK, REFDYNJ54242B;   4) OPEN HEART A&B, REFDYNJ901203C;   5) OPEN HEART A&B, REFDYNJ901203D;   6) ACDF-LF, REFDYNJ906681B;   7) ACDF-LF, REFDYNJ906681C.",
  "description": "FDA recall Z-0778-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) OPEN HEART CDS-LF, REFCDS840451M;   2) NEURO PACK, REFDYNJ41516M;   3) RFD- AAA PACK, REFDYNJ54242B;   4) OPEN HEART A&B, REFDYNJ901203C;   5) OPEN HEART A&B, REFDYNJ901203D;   6) ACDF-LF, REFDYNJ906681B;   7) ACDF-LF, REFDYNJ906681C. (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/",
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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-0778-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline custom medical procedure kits labeled as:    1) OPEN HEART CDS-LF, REFCDS840451M;   2) NEURO PACK, REFDYNJ41516M;   3) RFD- AAA PACK, REFDYNJ54242B;   4) OPEN HEART A&B, REFDYNJ901203C;   5) OPEN HEART A&B, REFDYNJ901203D;   6) ACDF-LF, REFDYNJ906681B;   7) ACDF-LF, REFDYNJ906681C.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0778-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0778-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline custom medical procedure kits labeled as:    1) OPEN HEART CDS-LF, REFCDS840451M;   2) NEURO PACK, REFDYNJ41516M;   3) RFD- AAA PACK, REFDYNJ54242B;   4) OPEN HEART A&B, REFDYNJ901203C;   5) OPEN HEART A&B, REFDYNJ901203D;   6) ACDF-LF, REFDYNJ906681B;   7) ACDF-LF, REFDYNJ906681C.",
      "text": "The FDA logged enforcement record Z-0778-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline custom medical procedure kits labeled as:    1) OPEN HEART CDS-LF, REFCDS840451M;   2) NEURO PACK, REFDYNJ41516M;   3) RFD- AAA PACK, REFDYNJ54242B;   4) OPEN HEART A&B, REFDYNJ901203C;   5) OPEN HEART A&B, REFDYNJ901203D;   6) ACDF-LF, REFDYNJ906681B;   7) ACDF-LF, REFDYNJ906681C. — reason: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-21. Affected lots/codes: 1) REF CDS840451M, UDI/DI  10195327417574 (EA) 40195327417575 (CS), Lot Numbers:  24BLA736;    2) REF DYNJ41516M, UDI/DI  10193489202564 (EA) 40193489202565 (CS), Lot Numbers:  19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171;   3) REF DYNJ54242B, UDI/DI  10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400;    4) REF DYNJ901203C, UDI/DI  10889942572526 (EA) 40889942572527 (CS), Lot numbers:  19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734;   5) REF DYNJ901203D, UDI/DI  10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830;    6) REF DYNJ906681B, UDI/DI  10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278;    7) REF DYNJ906681C, UDI/DI  10195327173838 (EA) 40195327173839 (CS) , Lot Numbers:  22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458.. 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-0778-2025&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-0778-2025&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-0778-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0778-2025 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-0778-2025&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-0778-2025&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-0778-2025/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-0778-2025",
      "numberOfItems": 9,
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        {
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0778-2025",
            "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": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-11-21",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF CDS840451M, UDI/DI  10195327417574 (EA) 40195327417575 (CS), Lot Numbers:  24BLA736;    2) REF DYNJ41516M, UDI/DI  10193489202564 (EA) 40193489202565 (CS), Lot Numbers:  19JKB417, 19LKA454, 20AKB109, 20DKB147, 20FKB171;   3) REF DYNJ54242B, UDI/DI  10195327167097 (EA) 40195327167098 (CS), Lot Numbers: 23GBO400;    4) REF DYNJ901203C, UDI/DI  10889942572526 (EA) 40889942572527 (CS), Lot numbers:  19BKA270, 19CKC053, 19EKD526, 19FKC478, 19HKA796, 19KKA783, 19LKB868, 20BKA558, 20FKA993, 20IKA397, 20LKA831, 21BKA583, 21DKA592, 21GMB734;   5) REF DYNJ901203D, UDI/DI  10193489947526 (EA) 40193489947527 (CS), Lot Numbers: 21GME287, 21JMH613, 22AMB438, 22CMD928, 22CMF425, 22EMF242, 22FMG716, 22GMH022, 22IMD195, 23AMB881, 23DME044, 23DME245, 23EMI884, 23HMH269, 23HMI447, 23LMB223, 24AMB281, 24CMI324, 24EMC691, 24EMI830;    6) REF DYNJ906681B, UDI/DI  10195327106881 (EA) 40195327106882 (CS), Lot Numbers: 22FBC663, 22OBM278;    7) REF DYNJ906681C, UDI/DI  10195327173838 (EA) 40195327173839 (CS) , Lot Numbers:  22IBR002, 22JBV571, 22JBW937, 22KBB923, 22LBK562, 23ABC493, 23GBR644, 23IBP138, 23IBV201, 23JBK264, 23LBE604, 23LBS964, 24CBP708, 24EBA703, 24GBL458.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}