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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1096-2024.jsonld",
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  "name": "MEDLINE Kits, trays, and packs labeled as follows:    a)\tDIALYSIS FISTULA KIT, REF DYNDC3106,   b)\tENDO KIT, REF DYKE1346D,   c)\tENDO KIT, REF DYKE1892A,   d)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)\tFREQUENT DAILY VAD, REF DYNDC3184,   g)\tIMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)\tINFANT COARTATION PACK, REF DYNJ54822D,   i)\tINFANT OPEN HEART PUMP, REF DYNJ904068D,   j)\tINFUSA PORT DRESSING KIT, REF DYNDC3192,   k)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)\tOPEN HEART ACCESSORY CDS, REF CDS984289K,   n)\tPACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)\tPERICARDIAL KIT, REF DYNDA2212B,   p)\tPK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554C",
  "description": "FDA recall Z-1096-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tDIALYSIS FISTULA KIT, REF DYNDC3106,   b)\tENDO KIT, REF DYKE1346D,   c)\tENDO KIT, REF DYKE1892A,   d)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)\tFREQUENT DAILY VAD, REF DYNDC3184,   g)\tIMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)\tINFANT COARTATION PACK, REF DYNJ54822D,   i)\tINFANT OPEN HEART PUMP, REF DYNJ904068D,   j)\tINFUSA PORT DRESSING KIT, REF DYNDC3192,   k)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)\tOPEN HEART ACCESSORY CDS, REF CDS984289K,   n)\tPACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)\tPERICARDIAL KIT, REF DYNDA2212B,   p)\tPK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554C (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",
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    "@type": "schema:MedicalDevice",
    "name": "MEDLINE Kits, trays, and packs labeled as follows:    a)\tDIALYSIS FISTULA KIT, REF DYNDC3106,   b)\tENDO KIT, REF DYKE1346D,   c)\tENDO KIT, REF DYKE1892A,   d)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)\tFREQUENT DAILY VAD, REF DYNDC3184,   g)\tIMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)\tINFANT COARTATION PACK, REF DYNJ54822D,   i)\tINFANT OPEN HEART PUMP, REF DYNJ904068D,   j)\tINFUSA PORT DRESSING KIT, REF DYNDC3192,   k)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)\tOPEN HEART ACCESSORY CDS, REF CDS984289K,   n)\tPACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)\tPERICARDIAL KIT, REF DYNDA2212B,   p)\tPK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554C",
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1096-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1096-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tDIALYSIS FISTULA KIT, REF DYNDC3106,   b)\tENDO KIT, REF DYKE1346D,   c)\tENDO KIT, REF DYKE1892A,   d)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)\tFREQUENT DAILY VAD, REF DYNDC3184,   g)\tIMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)\tINFANT COARTATION PACK, REF DYNJ54822D,   i)\tINFANT OPEN HEART PUMP, REF DYNJ904068D,   j)\tINFUSA PORT DRESSING KIT, REF DYNDC3192,   k)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)\tOPEN HEART ACCESSORY CDS, REF CDS984289K,   n)\tPACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)\tPERICARDIAL KIT, REF DYNDA2212B,   p)\tPK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554C",
      "text": "The FDA logged enforcement record Z-1096-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tDIALYSIS FISTULA KIT, REF DYNDC3106,   b)\tENDO KIT, REF DYKE1346D,   c)\tENDO KIT, REF DYKE1892A,   d)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648G,   e)\tENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I,   f)\tFREQUENT DAILY VAD, REF DYNDC3184,   g)\tIMPLANTED VASCULAR ACCESS, REF DYNDC2842,   h)\tINFANT COARTATION PACK, REF DYNJ54822D,   i)\tINFANT OPEN HEART PUMP, REF DYNJ904068D,   j)\tINFUSA PORT DRESSING KIT, REF DYNDC3192,   k)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165,   l)\tLVAD DRIVELINE MANAGEMENT KIT, REF DM1165B,   m)\tOPEN HEART ACCESSORY CDS, REF CDS984289K,   n)\tPACEMAKER PK SHSC-LF, REF DYNJ46785C,   o)\tPERICARDIAL KIT, REF DYNDA2212B,   p)\tPK, RADIOLOGY-PORTSMOUTH, REF DYNJ44087B,   q)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554A,   r)\tPUH PERCUTANEOUS ECMO, REF DYNJ907554C — reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: a) REF DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers:  21LBT706, 22CBE273;   b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963;    c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers:  10195327430962;   d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974;    e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers:  DYKE1648I;   f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184;   g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers:  DYNDC2842;   h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers:    i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127;   j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers:  23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898;   k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers:  DYNDC3192;   l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers:  23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425;    m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540;   n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers:  22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913;   o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers:  22ILA769, 22LLA799, 23BLB093, 23ELA493;   p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers:  23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577;   q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A;     r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers:  22IBF009, 22IBF810, 23ABS408, 23DBE286. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "operative": true
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1096-2024&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-1096-2024&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-1096-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1096-2024 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": {
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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-1096-2024&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-1096-2024&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-1096-2024/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": {
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        "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-1096-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1096-2024",
            "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 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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-15",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYNDC3106, UDI/DI 40193489913270 (case), 10193489913279 (unit), Lot Numbers:  21LBT706, 22CBE273;   b) REF DYKE1346D, UDI/DI 40195327114085 (case), 10195327114084 (unit), Lot Numbers: 22GBO510, 23BBG861, 23CBM313, 23EBN617, 23FBU655, 23GBR877, 23IBH963;    c) REF DYKE1892A, UDI/DI 40195327430963 (case), 10195327430962 (unit), Lot Numbers:  10195327430962;   d) REF DYKE1648G, UDI/DI 40195327007127 (case), 10195327007126 (unit), Lot Numbers: 22BBY253, 22DBG793, 22EBM485, 22GBY046, 22JBQ585, 22LBJ398, 23CBG974;    e) REF DYKE1648I, UDI/DI 40195327351541 (case), 10195327351540 (unit), Lot Numbers:  DYKE1648I;   f) REF DYNDC3184, UDI/DI 40195327034093 (case), 10195327034092 (unit), Lot Numbers: DYNDC3184;   g) REF DYNDC2842, UDI/DI 40193489342568 (case), 10193489342567 (unit), Lot Numbers:  DYNDC2842;   h) REF DYNJ54822D, UDI/DI 40195327151813 (case), 10195327151812 (unit), Lot Numbers:    i) REF DYNJ904068D, UDI/DI 22DMI181, 22GMH542, 23FMG372, 23GMC127;   j) REF DYNDC3192, UDI/DI 40195327153251 (case), 10195327153250 (unit), Lot Numbers:  23BMF718, 23CME669, 23FMJ514, 23GMH712, 23IMA898;   k) REF DM1165, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers:  DYNDC3192;   l) REF DM1165B, UDI/DI 40653160994184 (case), 10653160994183 (unit), Lot Numbers:  23BBA069, 23CBR900, 23DBR127, 23EBP048, 23GBF718, 23HBN448, 23JBB725, 23JBP425;    m) REF CDS984289K, UDI/DI 40195327067244 (case), 10195327067243 (unit), Lot Numbers: 22FBX071, 22JBT625, 22LBQ630, 22OBI364, 23ABP719, 23CBI370, 23FBP065, 23FBV540;   n) REF DYNJ46785C, UDI/DI 40888277789389 (case), 10888277789388 (unit), Lot Numbers:  22CBY383, 22HBI240, 22JBS870, 22LBR066, 23ABC131, 23BBJ268, 23BBK356, 23CBS913;   o) REF DYNDA2212B, UDI/DI 20193489197386 (case), 10193489197389 (unit), Lot Numbers:  22ILA769, 22LLA799, 23BLB093, 23ELA493;   p) REF DYNJ44087B, UDI/DI 40195327346585 (case), 10195327346584 (unit), Lot Numbers:  23BBR837, 23EBF536, 23FBL664, 23HBQ739, 23IBF826, 23JBR527, 23KBA577;   q) REF DYNJ907554A, UDI/DI 40195327024636 (case), 10195327024635 (unit), Lot Numbers: DYNJ907554A;     r) REF DYNJ907554C, UDI/DI 40195327183838 (case), 10195327183837 (unit), Lot Numbers:  22IBF009, 22IBF810, 23ABS408, 23DBE286",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}