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  "name": "Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.",
  "description": "FDA recall Z-1866-2025 — Zyno Medical LLC is recalling Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. (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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    "name": "Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.",
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      "name": "FDA recall Z-1866-2025: Zyno Medical LLC is recalling Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.",
      "text": "The FDA logged enforcement record Z-1866-2025: Zyno Medical LLC is voluntarily recalling Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. — reason: Unreleased software versions were installed on distributed devices without verification or validation.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-07. Affected lots/codes: Model No: Z800F; UDI-DI: 00814371020013; Serial No. 600091; 600133; 600203; 600259; 600320; 600361; 600404; 600446; 600482; 600526; 600565; 600601; 600094; 600138; 600204; 600261; 600321; 600362; 600406; 600447; 600483; 600528; 600566; 600603; 600095; 600139; 600206; 600262; 600322; 600363; 600407; 600449; 600485; 600529; 600568; 600604; 600099; 600141; 600207; 600263; 600323; 600364; 600408; 600450; 600487; 600531; 600569; 600605; 600100; 600142; 600209; 600265; 600324; 600369; 600410; 600451; 600488; 600532; 600570; 600608; 600102; 600143; 600211; 600266; 600325; 600370; 600411; 600452; 600489; 600533; 600571; 600609; 600104; 600146; 600215; 600267; 600326; 600376; 600412; 600453; 600490; 600535; 600572; 600610; 600105; 600148; 600217; 600268; 600328; 600377; 600414; 600454; 600495 600536; 600573; 600611; 600106; 600150; 600220; 600270; 600330; 600378; 600415; 600456; 600496; 600539; 600574; 600612; 600108; 600151; 600223; 600271; 600331; 600379; 600416; 600457; 600498; 600540; 600575; 600613; 600109; 600152; 600224; 600289; 600335; 600383; 600417; 600458; 600499; 600541; 600576; 600614; 600110; 600153; 600227; 600292; 600336; 600384; 600418; 600460; 600504; 600542; 600577; 600615; 600111; 600154; 600228; 600294; 600338; 600385; 600419; 600461; 600505; 600543; 600578; 600617; 600112; 600155; 600229; 600295; 600339; 600386; 600422; 600462; 600506; 600545; 600579; 600618; 600113; 600156; 600230; 600297; 600341; 600387; 600423; 600464; 600509; 600546; 600580; 600921; 600114; 600157; 600231; 600298; 600342; 600388; 600424; 600465; 600510; 600549; 600583; 601325; 600115; 600158; 600235; 600299; 600343; 600389; 600425; 600466; 600511; 600551; 600584; 601433; 600116; 600159; 600238; 600300; 600344; 600391; 600427; 600467; 600513; 600553; 600585; 601514; 600118; 600160; 600239; 600301; 600347; 600392; 600430; 600470; 600514; 600554; 600586; 601603; 600120; 600161; 600240; 600302; 600348; 600393; 600431; 600471; 600516; 600555; 600587; 601651; 600121; 600162; 600249; 600303; 600349; 600394; 600432; 600473; 600517; 600556; 600589; 602578; 600122; 600164; 600250; 600304; 600350; 600396; 600436; 600474; 600518; 600557; 600591; 602743; 600126; 600165; 600251; 600305; 600351; 600398; 600437; 600475; 600519; 600558; 600592; 602807; 600127; 600168; 600252; 600306; 600352; 600399; 600438; 600476; 600520; 600559; 600594; 603858; 600129; 600174; 600253; 600308; 600353; 600400; 600440; 600477; 600521; 600560; 600595; 604637; 600130; 600176; 600254; 600309; 600356; 600401; 600442; 600478; 600522; 600562; 600596; 605411; 600131; 600188; 600255; 600310; 600357; 600402; 600443; 600480; 600523; 600563; 600599; 605870; 600132; 600192; 600257; 600319; 600359; 600403; 600445; 600481; 600525; 600564; 600600; 605918; 605964; 606886; 607077; 607891; 608058; 608061; 608612; 613123; 614776.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1866-2025 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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      "reviewStatus": "current",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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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."
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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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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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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