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  "name": "Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY",
  "description": "FDA recall Z-0629-2024 — Merit Medical Systems, Inc. is recalling Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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      "name": "FDA recall Z-0629-2024: Merit Medical Systems, Inc. is recalling Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY",
      "text": "The FDA logged enforcement record Z-0629-2024: Merit Medical Systems, Inc. is voluntarily recalling Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY — reason: The sterility of microcatheter and infusion system devices cannot be guaranteed.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-06. Affected lots/codes: REF: IS4-135-30  Lot # H2765720 UDI: 00884450000885  REF: IS4-90-10  Lot # H2765603 UDI: 00884450006504. A RECORDED FDA enforcement action (occurred=true).",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-0629-2024 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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      "@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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            "Value": "Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, \tKS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.",
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