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  "name": "Novum IQ Syringe infusion system, Product Code 40800BAXUS",
  "description": "FDA recall Z-0151-2024 — Baxter Healthcare Corporation is recalling Novum IQ Syringe infusion system, Product Code 40800BAXUS (Devices, Class I). 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-0151-2024: Baxter Healthcare Corporation is recalling Novum IQ Syringe infusion system, Product Code 40800BAXUS",
      "text": "The FDA logged enforcement record Z-0151-2024: Baxter Healthcare Corporation is voluntarily recalling Novum IQ Syringe infusion system, Product Code 40800BAXUS — reason: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an  Infusion Complete  alarm even though uninfused fluid remains in the syringe.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-13. Affected lots/codes: All Serial Numbers. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-0151-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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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      "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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      "epistemicStatus": {
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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": "US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.",
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