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  "name": "Bicarby Dialysate; Model number: RFP-400-G;",
  "description": "FDA recall Z-2401-2026 — Fresenius Medical Care Holdings, Inc. is recalling Bicarby Dialysate; Model number: RFP-400-G; (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": "Bicarby Dialysate; Model number: RFP-400-G;",
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      "name": "FDA recall Z-2401-2026: Fresenius Medical Care Holdings, Inc. is recalling Bicarby Dialysate; Model number: RFP-400-G;",
      "text": "The FDA logged enforcement record Z-2401-2026: Fresenius Medical Care Holdings, Inc. is voluntarily recalling Bicarby Dialysate; Model number: RFP-400-G; — reason: There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-05-07. Affected lots/codes: Model number: RFP-400-G; UDI-DI: 00840861102839; Lot codes: 25SG06026, 25SG06027;. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-2401-2026 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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          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic: TX.",
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