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  "name": "Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00",
  "description": "FDA recall Z-0224-2025 — Spectrum Medical Ltd. is recalling Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00 (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": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0224-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00",
    "manufacturer": {
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      "name": "Spectrum Medical Ltd."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0224-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0224-2025: Spectrum Medical Ltd. is recalling Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00",
      "text": "The FDA logged enforcement record Z-0224-2025: Spectrum Medical Ltd. is voluntarily recalling Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers:  a) 51-000013-00, b) 51-000008-00 — reason: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-03-13. Affected lots/codes: UDI/DI 05060434420770:  Serial Numbers:  a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, AU6004578, AU6004579, AU6004580, AU6004587, AU6004588, AU6004590, AU6004591, AU6004603, AU6004604, AU6004605, AU6004606, AU6004607, AU6004609, AU6004610, AU6004613, AU6004731, AU6004771, AU6004773, AU6004776, AU6004777, AU6004778, AU6004779, AU6004781, AU6004782, AU6004919, AU6004920, AU6004921, AU6004922, AU6004923, AU6004924, AU6004925, AU6004926, AU6004927, AU6004929, AU6004930, AU6004955, AU6004957, AU6004958, AU6004960, AU6004963, AU6004966, AU6004968, AU6004970, AU6004971, AU6004972, AU6005010, AU6005021, AU6005022, AU6005023, AU6005024, AU6005025, AU6005026, AU6005027, AU6005028, AU6005029, AU6005030, AU6005037, AU6005038, AU6005039, AU6005040, AU6005041, AU6005042, AU6005057, AU6005065, AU6005109, AU6005110, AU6005118, AU6005124, AU6005125, AU6005355, AU6006351;   Serial Numbers:  b) AU8001273, AU8001275, AU8001346, AU8001347, AU8001348, AU8001359, AU8001360, AU8001366, AU8001403, AU8001406, AU8001407, AU8001446, AU8001447, AU8001449. A RECORDED FDA enforcement action (occurred=true).",
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0224-2025&lang=eng",
        "value": "Devices recall, status Completed",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0224-2025&lang=eng"
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0224-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0224-2025 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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      "reviewStatus": "current",
      "commercialInfluence": false,
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        "adjudged": true,
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0224-2025&lang=eng"
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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-0224-2025/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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            "Value": "Z-0224-2025",
            "Status": "recorded"
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            "Value": "Devices",
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Spectrum Medical Ltd.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.",
            "Status": "recorded"
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-03-13",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI/DI 05060434420770:  Serial Numbers:  a) AU6004040, AU6004041, AU6004042, AU6004043, AU6004044, AU6004046, AU6004050, AU6004051, AU6004052, AU6004053, AU6004054, AU6004056, AU6004057, AU6004058, AU6004060, AU6004061, AU6004062, AU6004063, AU6004064, AU6004065, AU6004066, AU6004069, AU6004070, AU6004071, AU6004072, AU6004073, AU6004074, AU6004075, AU6004136, AU6004137, AU6004138, AU6004139, AU6004140, AU6004141, AU6004142, AU6004143, AU6004144, AU6004145, AU6004146, AU6004147, AU6004148, AU6004159, AU6004160, AU6004161, AU6004162, AU6004167, AU6004168, AU6004169, AU6004170, AU6004171, AU6004172, AU6004173, AU6004174, AU6004175, AU6004176, AU6004177, AU6004178, AU6004179, AU6004180, AU6004181, AU6004182, AU6004183, AU6004184, AU6004185, AU6004186, AU6004187, AU6004188, AU6004195, AU6004197, AU6004198, AU6004200, AU6004201, AU6004202, AU6004203, AU6004204, AU6004205, AU6004207, AU6004332, AU6004333, AU6004348, AU6004349, AU6004350, AU6004352, AU6004353, AU6004354, AU6004532, AU6004577, AU6004578, AU6004579, AU6004580, AU6004587, AU6004588, AU6004590, AU6004591, AU6004603, AU6004604, AU6004605, AU6004606, AU6004607, AU6004609, AU6004610, AU6004613, AU6004731, AU6004771, AU6004773, AU6004776, AU6004777, AU6004778, AU6004779, AU6004781, AU6004782, AU6004919, AU6004920, AU6004921, AU6004922, AU6004923, AU6004924, AU6004925, AU6004926, AU6004927, AU6004929, AU6004930, AU6004955, AU6004957, AU6004958, AU6004960, AU6004963, AU6004966, AU6004968, AU6004970, AU6004971, AU6004972, AU6005010, AU6005021, AU6005022, AU6005023, AU6005024, AU6005025, AU6005026, AU6005027, AU6005028, AU6005029, AU6005030, AU6005037, AU6005038, AU6005039, AU6005040, AU6005041, AU6005042, AU6005057, AU6005065, AU6005109, AU6005110, AU6005118, AU6005124, AU6005125, AU6005355, AU6006351;   Serial Numbers:  b) AU8001273, AU8001275, AU8001346, AU8001347, AU8001348, AU8001359, AU8001360, AU8001366, AU8001403, AU8001406, AU8001407, AU8001446, AU8001447, AU8001449",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.",
            "Status": "recorded"
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