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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0351-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "BD Extension Sets (Product Name, Catalog #)    BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902    BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite\" VALVES, Catalog #  20062E;   BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog #  70000N-07;   BD MaxGuardTM tri-fuse extension set, Catalog #  ME1224;  BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog #  20350ET;   BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog #  70001B-07T.",
  "description": "FDA recall Z-0351-2024 — Becton Dickinson & Company is recalling BD Extension Sets (Product Name, Catalog #)    BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902    BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite\" VALVES, Catalog #  20062E;   BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog #  70000N-07;   BD MaxGuardTM tri-fuse extension set, Catalog #  ME1224;  BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog #  20350ET;   BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog #  70001B-07T. (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/",
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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-0351-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD Extension Sets (Product Name, Catalog #)    BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902    BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite\" VALVES, Catalog #  20062E;   BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog #  70000N-07;   BD MaxGuardTM tri-fuse extension set, Catalog #  ME1224;  BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog #  20350ET;   BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog #  70001B-07T.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Becton Dickinson & Company"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0351-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0351-2024: Becton Dickinson & Company is recalling BD Extension Sets (Product Name, Catalog #)    BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902    BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite\" VALVES, Catalog #  20062E;   BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog #  70000N-07;   BD MaxGuardTM tri-fuse extension set, Catalog #  ME1224;  BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog #  20350ET;   BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog #  70001B-07T.",
      "text": "The FDA logged enforcement record Z-0351-2024: Becton Dickinson & Company is voluntarily recalling BD Extension Sets (Product Name, Catalog #)    BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902    BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite\" VALVES, Catalog #  20062E;   BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog #  70000N-07;   BD MaxGuardTM tri-fuse extension set, Catalog #  ME1224;  BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog #  20350ET;   BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog #  70001B-07T. — reason: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-11. Affected lots/codes: UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI:  07613203011853, Catalog #  20062E;  UDI-DI:  10885403226120, Catalog #  70000N-07;  UDI-DI:  10885403236112, Catalog #  ME1224;  UDI-DI:  10885403229756, Catalog #  20350ET;  UDI-DI:  10885403240997, Catalog #  70001B-07T.  All lots, thru expiration date October 16, 2026.. 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": {
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        "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-0351-2024&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-0351-2024&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-0351-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0351-2024 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": {
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        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-0351-2024/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,
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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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0351-2024",
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            "Field": "Recall number",
            "Value": "Z-0351-2024",
            "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 II",
            "Status": "determination"
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          "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": "Becton Dickinson & Company",
            "Status": "recorded"
          }
        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-10-11",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI:  07613203011853, Catalog #  20062E;  UDI-DI:  10885403226120, Catalog #  70000N-07;  UDI-DI:  10885403236112, Catalog #  ME1224;  UDI-DI:  10885403229756, Catalog #  20350ET;  UDI-DI:  10885403240997, Catalog #  70001B-07T.  All lots, thru expiration date October 16, 2026.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}