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  "name": "QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388",
  "description": "FDA recall Z-1641-2023 — Maquet Medical Systems USA is recalling QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388 (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1641-2023&lang=eng",
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    "name": "QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388",
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      "name": "FDA recall Z-1641-2023: Maquet Medical Systems USA is recalling QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388",
      "text": "The FDA logged enforcement record Z-1641-2023: Maquet Medical Systems USA is voluntarily recalling QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388 — reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's  sterile pouch.  2. Product packaging may exhibit holes, cracks, dents, and crushed areas.     Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: Model                        Item No.           UDI-DI HMO 30000-USA      701070384       4058863153681 HMO 31000-USA      701070388       4058863154299 All lots. 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1641-2023/fda-classification",
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      "name": "FDA classified recall Z-1641-2023 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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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1641-2023/boundary",
      "@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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        "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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            "Field": "Reason",
            "Value": "1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's  sterile pouch.  2. Product packaging may exhibit holes, cracks, dents, and crushed areas.     Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.",
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