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  "name": "Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen",
  "description": "FDA recall Z-1873-2025 — Cardinal Health 200, LLC is recalling Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen (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": "Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen",
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      "name": "FDA recall Z-1873-2025: Cardinal Health 200, LLC is recalling Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen",
      "text": "The FDA logged enforcement record Z-1873-2025: Cardinal Health 200, LLC is voluntarily recalling Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen — reason: Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-02. Affected lots/codes: UDI-DI (ea) 10192253040319; UDI-DI (box) 50192253040317 Lots 2427700158 2425600066 2433000005 2427700160 2425600067 2425600070 2415100113 2425600071 2427700159 2415100110 2412100093 2433000095 2425600069 2425600077 2415100116 2425600063 2425600074 2415100115 2415100114 2412100096 2425600072 2425600075 2404400061 2425600064 2415100106 2425600076 2415100107 2415100112 2425600073 2425600065 2404400062 2404400065 2415100093 2415100109 2415100111 2433000094. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1873-2025 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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      "@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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