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  "name": "URINE KIT, SKU DYKM1845; Component No. 503581",
  "description": "FDA recall Z-0360-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling URINE KIT, SKU DYKM1845; Component No. 503581 (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-0360-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling URINE KIT, SKU DYKM1845; Component No. 503581",
      "text": "The FDA logged enforcement record Z-0360-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling URINE KIT, SKU DYKM1845; Component No. 503581 — reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-23. Affected lots/codes: UDI/DI: 40193489713993 (Case),  10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 22DMI870 22FMA088 22HMH213 22JMH449 22LMH860 23CMA518 23CMG948 23DMG087 23EMH568 23GMD322 23HME585 23IMG193 23KMD763 24AMD430 24CMA930 24CMD335 24DMA485 24FMF320 24GMJ197 24IME270. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0360-2025 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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