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  "name": "Monoject 20 mL Syringe Luer-Lock Tip Soft Pack",
  "description": "FDA recall Z-0148-2024 — Cardinal Health 200, LLC is recalling Monoject 20 mL Syringe Luer-Lock Tip Soft Pack (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": "FDA recall Z-0148-2024: Cardinal Health 200, LLC is recalling Monoject 20 mL Syringe Luer-Lock Tip Soft Pack",
      "text": "The FDA logged enforcement record Z-0148-2024: Cardinal Health 200, LLC is voluntarily recalling Monoject 20 mL Syringe Luer-Lock Tip Soft Pack — reason: Demonstrated recognition and compatibility issues with syringe infusion pumps.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-20. Affected lots/codes: Product Code: 1182000777;   UDI/DI: 10192253034677 - each, 20192253034674 - box, 50192253034675 - case;    Lot Numbers: 221201, 221202, 221203, 221204, 221205, 230201, 230202, 230203, 230204, 230205, 230206. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0148-2024 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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      "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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