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  "name": "BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9",
  "description": "FDA recall Z-2486-2024 — CareFusion 303, Inc. is recalling BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 (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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2486-2024/enforcement-record",
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      "name": "FDA recall Z-2486-2024: CareFusion 303, Inc. is recalling BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9",
      "text": "The FDA logged enforcement record Z-2486-2024: CareFusion 303, Inc. is voluntarily recalling BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 — reason: Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-24. Affected lots/codes: UDI: 10885403512544/ Serial Number: 16170661  16210908 16089019 16062433 16147169 16080412 16124906 15940375 15940373 15940374 15940376 15957620 15957621 15941307 15967410 15967412 15967409 15967413 15967411 15967361 15943774 16056924 16188928 15943781 15943470 15943782 15872417 15902417 15902418 15888968 15253736 15253737 16247094 16283979 16225069 16222611 16165533 16205727 16270832 16200474 16244810 16250223 15935617 15654707 15654706 15489245 15723803 15927979 15924532 15569608 15832680 15832679 15824206 15815815 15815825 15415136 15415135 15415137 15415138 15622987 16174396 16193269 15939084 15939085 15854218 15854728 15854727 15398915 15383489 15489244 15489243 15606150 15606167 15924529 15888948 15924530 15924528 15569630 15575989 15575996 15575979 15575978 15575988 15575986 15575985 15569629 15575975 15587203 15587204 15587205 15824205 15824210 15824221 15815826 15815830 15852349 15852348 15353925 15353926 15422146 15422154 15422152 15422155 15422153 15422149 15422148 15422151 15422147 15422156 15422158 15422157 15939254 15939255 15783795 15783783 15853040 15398907 15398905 15398913 15666771 15226385 15227522 15204115 15204117 15550828 15550861 15929562 15929561 15929563 15930792 15930790 15930783 15930785 15930791 15930788 15930784 15930789 15930787 15930793 15929564 15930786 15645828 15645826 15645830 15248755 15248757 15248758 15282139 15282134 15295949 15353927 15353929 15353930 15282137 15257953 15282141 15260920 15920015 15920012 15920013 15921449 15921445 15921447 15921741 15921742 15921740 15921743 15363281 15923974 15923971 15923973 15923975 15923970 15923972 15504830 15504825 15504832 15504827 15504820 15504822 15504819 15504829 15504823 15639723 15639722 15639729 15933707 15933710 15933713 15933709 15933708 15933715 15933714 15933711 15933739 15935598 15935594 15935592 15935628 15935590 15935587 15935588 15935589 15935599 15935593 15935591 15935600 15935595 15935601 15935602 15935625 15935624 15743383 15600756 15600757 15441364 15441362 15441367 15441366 15442781 15442784 15442783 15442785 15786145 16102550 15328505 15398903 16160290 16051740 16151587 16143255 16143254. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2486-2024 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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      "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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      "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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      "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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