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  "name": "2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.",
  "description": "FDA recall Z-1869-2024 — Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, 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": "2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.",
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      "name": "FDA recall Z-1869-2024: Fresenius Medical Care Holdings, Inc. is recalling 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.",
      "text": "The FDA logged enforcement record Z-1869-2024: Fresenius Medical Care Holdings, Inc. is voluntarily recalling 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, 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 2024-04-17. Affected lots/codes: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909,. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1869-2024&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-1869-2024&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1869-2024/fda-classification",
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      "name": "FDA classified recall Z-1869-2024 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.",
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        "value": "Class II",
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        }
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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",
        "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": "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": "Lot/code info",
            "Value": "Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909,",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}