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  "name": "SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.",
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      "name": "FDA recall Z-0695-2024: SoClean, Inc is recalling SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System.",
      "text": "The FDA logged enforcement record Z-0695-2024: SoClean, Inc is voluntarily recalling SoClean 2, REF SC1200, Supplemental Hose and Mask Maintenance System. — reason: New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: UPC: 187293000860. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0695-2024 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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