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  "name": "Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip  Soft Pack, REF 1180300777",
  "description": "FDA recall Z-0852-2024 — Cardinal Health 200, LLC is recalling Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip  Soft Pack, REF 1180300777 (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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    "name": "Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip  Soft Pack, REF 1180300777",
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      "name": "FDA recall Z-0852-2024: Cardinal Health 200, LLC is recalling Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip  Soft Pack, REF 1180300777",
      "text": "The FDA logged enforcement record Z-0852-2024: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip  Soft Pack, REF 1180300777 — reason: Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-12-28. Affected lots/codes: UDI/DI 50192253033517 (Case), 20192253033516 (Box), 10192253033519 (Each), Lot Numbers:  230201, 230202, 221201, 221202, 230203, 230204, 230205, 230206, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230207, 230602, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-0852-2024 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.",
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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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      "@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.",
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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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            "Field": "Reason",
            "Value": "Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.",
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