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  "name": "PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).",
  "description": "FDA recall Z-1544-2026 — Physio-Control, Inc. is recalling PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs). (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).",
    "manufacturer": {
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      "name": "Physio-Control, Inc."
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      "name": "FDA recall Z-1544-2026: Physio-Control, Inc. is recalling PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).",
      "text": "The FDA logged enforcement record Z-1544-2026: Physio-Control, Inc. is voluntarily recalling PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes  Catalog Numbers: 11101-000016  UDI-DI code: 00721902629013    Catalog Number: 11101-000017  UDI-DI code: 00721902682483    Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs). — reason: Due to pediatric defibrillator electrode delamination. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-21. Affected lots/codes: Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013  Catalog Number: 11101-000017 UDI-DI code: 00721902682483  Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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."
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      "name": "FDA classified recall Z-1544-2026 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.",
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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."
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      "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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Value": "Physio-Control, Inc.",
            "Status": "recorded"
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            "Value": "Due to pediatric defibrillator electrode delamination",
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            "Field": "Initiated",
            "Value": "2026-01-21",
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            "Value": "Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013  Catalog Number: 11101-000017 UDI-DI code: 00721902682483  Lot Numbers: 315303, 315639, 315858, 316007, 320529, 318931",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, 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, and WV. The countries of  Australia, Canada, Hong Kong, Japan, Mexico, Malaysia, Netherlands, New Zealand, and Taiwan.",
            "Status": "recorded"
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