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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1904-2025.jsonld",
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  "name": "Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA     AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version    The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.",
  "description": "FDA recall Z-1904-2025 — SunMed Holdings, LLC is recalling Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA     AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version    The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1904-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA     AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version    The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.",
    "manufacturer": {
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      "name": "SunMed Holdings, LLC"
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1904-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1904-2025: SunMed Holdings, LLC is recalling Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA     AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version    The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.",
      "text": "The FDA logged enforcement record Z-1904-2025: SunMed Holdings, LLC is voluntarily recalling Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA     AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version    The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. — reason: The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-15. Affected lots/codes: UDI-DI EA: 10889483588970 CS: 30889483588974  Lot 0004316661. 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-1904-2025&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-1904-2025&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-1904-2025/fda-classification",
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      "name": "FDA classified recall Z-1904-2025 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.",
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        "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-1904-2025&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-1904-2025/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": {
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        "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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  ],
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      "name": "FDA recall details — Z-1904-2025",
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            "Value": "Class I",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "SunMed Holdings, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.",
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            "Field": "Initiated",
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            "Value": "UDI-DI EA: 10889483588970 CS: 30889483588974  Lot 0004316661",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution nationwide. International distribution to Canada.",
            "Status": "recorded"
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