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  "name": "Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777",
  "description": "FDA recall Z-0112-2024 — Cardinal Health 200, LLC is recalling Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777 (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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      "name": "FDA recall Z-0112-2024: Cardinal Health 200, LLC is recalling Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777",
      "text": "The FDA logged enforcement record Z-0112-2024: Cardinal Health 200, LLC is voluntarily recalling Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777 — reason: Syringe contains conical tip that is not compatible with certain needleless IV connector(s).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-13. Affected lots/codes: Model Number/Product Code: 1180100777.    UDI/DI: 10192253034530 each, 20192253034537 box, 50192253034538 case.    Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0112-2024 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.",
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      "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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