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  "name": "190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A",
  "description": "FDA recall Z-2340-2024 — Fresenius Medical Care Holdings, Inc. is recalling 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A (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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    "name": "190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A",
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      "name": "FDA recall Z-2340-2024: Fresenius Medical Care Holdings, Inc. is recalling 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A",
      "text": "The FDA logged enforcement record Z-2340-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A — reason: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-03. Affected lots/codes: Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032, 7K0S300031, 7K0S300059, 7K0S300017, 7K0S300066, 6K0S163669, 5K0S193667, 5K0S193669, 5K0S193670, 5K0S193672, 5K0S193674, 5K0S193675, 5K0S194147, 5K0S194152, 5K0S194154, 5K0S194177, 6K0S169444, 6K0S172007, 6K0S165410, 6K0S167031, 6K0S171195, 6K0S171197, 6K0S171209, 5K0S194180, 7K0S300024, 5K0S193169, 6K0S169447, 6K0S169440, 6K0S172012, 6K0S172017, 6K0S159418, 6K0S169462, 6K0S167042, 7K0S300053, 6K0S167040, 6K0S167041, 4K0S190313, 5K0S194158, 6K0S171201, 6K0S169436, 5K0S193315, 7K0S300014, 6K0S162835, 6K0S162836, 6K0S167034, 6K0S167052, 7K0S300091, 6K0S159428, 5K0S194153, 5K0S193336, 6K0S169438, 6K0S169450, 7K0S300043, 5K0S194160, 7K0S300071, 7K0S300005, 6K0S172011, 6K0S169452, 6K0S172005, 5K0S193144, 7K0S300058, 5K0S193328, 6K0S159421, 5K0S194163, 6K0S169449, 6K0S169453, 6K0S171204, 7K0S300010, 7K0S300089, 6K0S163668, 6K0S159424, 6K0S159431, 6K0S167037, 5K0S193665, 7K0S300028, 5K0S193160, 6K0S167039, 7K0S300093, 7K0S300095, 6K0S163674, 7K0S300022, 5K0S193163, 5K0S194148, 6K0S172018, 6K0S165414, 6K0S163672, 6K0S163681, 6K0S163676, 6K0S163680, 6K0S169437, 7K0S300035, 5K0S193152, 6K0S159420, 6K0S169439, 6K0S169464, 6K0S171198, 6K0S171206, 6K0S171999, 6K0S172016, 6K0S172020, 6K0S169457, 6K0S172002, 6K0S172013, 6K0S162833, 6K0S165411, 6K0S165413, 7K0S300102, 7K0S300033, 5K0S194150, 6K0S162832, 6K0S169445, 5K0S193168, 5K0S194149, 6K0S163682, 6K0S162839, 6K0S167047, 6K0S171196, 5K0S194157, 5K0S193334, 7K0S300103, 6K0S169434, 6K0S162831, 6K0S163673, 6K0S172014, 6K0S163675, 6K0S163685, 7K0S300021, 6K0S163666, 5K0S193154, 5K0S193325, 6K0S165408, 5K0S193143, 5K0S193158, 5K0S194168, 7K0S300078, 5K0S193149, 5K0S193157, 5K0S193170, 7K0S300030, 5K0S193323, 5K0S193331, 7K0S300107, 6K0S159419, 6K0S159426, 6K0S169456, 7K0S300087, 7K0S300075, 5K0S194151, 6K0S163686, 7K0S300029, 5K0S193156, 5K0S193164, 6K0S169460, 6K0S167043, 6K0S167048, 6K0S167050, 6K0S169465, 7K0S300070, 7K0S300068, 6K0S167053, 6K0S167033, 6K0S167055, 6K0S167032, 5K0S193171, 5K0S193172, 6K0S169443, 6K0S167046, 7K0S300042, 5K0S194171, 4K0S190319, 5K0S193330, 5K0S193153, 5K0S193671, 5K0S194175, 6K0S169466, 6K0S169467, 6K0S171995, 6K0S172003, 6K0S169461, 6K0S171202, 6K0S171210, 6K0S171199, 6K0S171207, 6K0S171211, 6K0S172009, 5K0S193333, 6K0S163667, 6K0S163671, 6K0S172015, 6K0S171996, 6K0S171997, 5K0S193316, 6K0S163679, 6K0S172000, 7K0S300072, 7K0S300100, 7K0S300008, 7K0S300020, 7K0S300026, 6K0S171998, 5K0S193335, 5K0S194165, 6K0S162827, 6K0S162828, 6K0S162838, 6K0S162843, 5K0S193329, 5K0S193148, 5K0S193145, 5K0S193150, 6K0S162841, 5K0S193668, 6K0S159416, 6K0S162846, 6K0S167038, 5K0S194170, 4K0S190309, 5K0S193155, 5K0S193679, 5K0S194155, 6K0S169454, 6K0S169463, 6K0S159422, 6K0S159425, 6K0S169435, 6K0S167054, 6K0S172006, 6K0S172024, 6K0S171208, 6K0S172004, 6K0S169451, 6K0S163678, 7K0S300047, 7K0S300051, 7K0S300054, 7K0S300064, 7K0S300065, 7K0S300076, 7K0S300098, 6K0S169459, 6K0S167036, 6K0S169455, 5K0S193321, 5K0S193666, 5K0S193673, 7K0S300106, 7K0S300104, 6K0S167030, 7K0S300041, 7K0S300050, 7K0S300052, 7K0S300057, 7K0S300090,. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": 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-2340-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-2340-2024&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-2340-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2340-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2340-2024&lang=eng",
        "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-2340-2024&lang=eng"
        }
      },
      "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-2340-2024/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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2340-2024",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2340-2024",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Fresenius Medical Care Holdings, Inc.",
            "Status": "recorded"
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          "position": 6,
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            "Field": "Reason",
            "Value": "An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-06-03",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032, 7K0S300031, 7K0S300059, 7K0S300017, 7K0S300066, 6K0S163669, 5K0S193667, 5K0S193669, 5K0S193670, 5K0S193672, 5K0S193674, 5K0S193675, 5K0S194147, 5K0S194152, 5K0S194154, 5K0S194177, 6K0S169444, 6K0S172007, 6K0S165410, 6K0S167031, 6K0S171195, 6K0S171197, 6K0S171209, 5K0S194180, 7K0S300024, 5K0S193169, 6K0S169447, 6K0S169440, 6K0S172012, 6K0S172017, 6K0S159418, 6K0S169462, 6K0S167042, 7K0S300053, 6K0S167040, 6K0S167041, 4K0S190313, 5K0S194158, 6K0S171201, 6K0S169436, 5K0S193315, 7K0S300014, 6K0S162835, 6K0S162836, 6K0S167034, 6K0S167052, 7K0S300091, 6K0S159428, 5K0S194153, 5K0S193336, 6K0S169438, 6K0S169450, 7K0S300043, 5K0S194160, 7K0S300071, 7K0S300005, 6K0S172011, 6K0S169452, 6K0S172005, 5K0S193144, 7K0S300058, 5K0S193328, 6K0S159421, 5K0S194163, 6K0S169449, 6K0S169453, 6K0S171204, 7K0S300010, 7K0S300089, 6K0S163668, 6K0S159424, 6K0S159431, 6K0S167037, 5K0S193665, 7K0S300028, 5K0S193160, 6K0S167039, 7K0S300093, 7K0S300095, 6K0S163674, 7K0S300022, 5K0S193163, 5K0S194148, 6K0S172018, 6K0S165414, 6K0S163672, 6K0S163681, 6K0S163676, 6K0S163680, 6K0S169437, 7K0S300035, 5K0S193152, 6K0S159420, 6K0S169439, 6K0S169464, 6K0S171198, 6K0S171206, 6K0S171999, 6K0S172016, 6K0S172020, 6K0S169457, 6K0S172002, 6K0S172013, 6K0S162833, 6K0S165411, 6K0S165413, 7K0S300102, 7K0S300033, 5K0S194150, 6K0S162832, 6K0S169445, 5K0S193168, 5K0S194149, 6K0S163682, 6K0S162839, 6K0S167047, 6K0S171196, 5K0S194157, 5K0S193334, 7K0S300103, 6K0S169434, 6K0S162831, 6K0S163673, 6K0S172014, 6K0S163675, 6K0S163685, 7K0S300021, 6K0S163666, 5K0S193154, 5K0S193325, 6K0S165408, 5K0S193143, 5K0S193158, 5K0S194168, 7K0S300078, 5K0S193149, 5K0S193157, 5K0S193170, 7K0S300030, 5K0S193323, 5K0S193331, 7K0S300107, 6K0S159419, 6K0S159426, 6K0S169456, 7K0S300087, 7K0S300075, 5K0S194151, 6K0S163686, 7K0S300029, 5K0S193156, 5K0S193164, 6K0S169460, 6K0S167043, 6K0S167048, 6K0S167050, 6K0S169465, 7K0S300070, 7K0S300068, 6K0S167053, 6K0S167033, 6K0S167055, 6K0S167032, 5K0S193171, 5K0S193172, 6K0S169443, 6K0S167046, 7K0S300042, 5K0S194171, 4K0S190319, 5K0S193330, 5K0S193153, 5K0S193671, 5K0S194175, 6K0S169466, 6K0S169467, 6K0S171995, 6K0S172003, 6K0S169461, 6K0S171202, 6K0S171210, 6K0S171199, 6K0S171207, 6K0S171211, 6K0S172009, 5K0S193333, 6K0S163667, 6K0S163671, 6K0S172015, 6K0S171996, 6K0S171997, 5K0S193316, 6K0S163679, 6K0S172000, 7K0S300072, 7K0S300100, 7K0S300008, 7K0S300020, 7K0S300026, 6K0S171998, 5K0S193335, 5K0S194165, 6K0S162827, 6K0S162828, 6K0S162838, 6K0S162843, 5K0S193329, 5K0S193148, 5K0S193145, 5K0S193150, 6K0S162841, 5K0S193668, 6K0S159416, 6K0S162846, 6K0S167038, 5K0S194170, 4K0S190309, 5K0S193155, 5K0S193679, 5K0S194155, 6K0S169454, 6K0S169463, 6K0S159422, 6K0S159425, 6K0S169435, 6K0S167054, 6K0S172006, 6K0S172024, 6K0S171208, 6K0S172004, 6K0S169451, 6K0S163678, 7K0S300047, 7K0S300051, 7K0S300054, 7K0S300064, 7K0S300065, 7K0S300076, 7K0S300098, 6K0S169459, 6K0S167036, 6K0S169455, 5K0S193321, 5K0S193666, 5K0S193673, 7K0S300106, 7K0S300104, 6K0S167030, 7K0S300041, 7K0S300050, 7K0S300052, 7K0S300057, 7K0S300090,",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Domestic: Nationwide Distribution.  International: Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}