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  "name": "BD Pyxis CII Safe ES, REF: 1116-00",
  "description": "FDA recall Z-0672-2025 — CareFusion 303, Inc. is recalling BD Pyxis CII Safe ES, REF: 1116-00 (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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    "name": "BD Pyxis CII Safe ES, REF: 1116-00",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0672-2025/enforcement-record",
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      "name": "FDA recall Z-0672-2025: CareFusion 303, Inc. is recalling BD Pyxis CII Safe ES, REF: 1116-00",
      "text": "The FDA logged enforcement record Z-0672-2025: CareFusion 303, Inc. is voluntarily recalling BD Pyxis CII Safe ES, REF: 1116-00 — reason: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-14. Affected lots/codes: All software versions. REF/UDI-DI:  1116-00/10885403512605/ 15938609 15938608 15960426 15977244 15977243 15997587 15997584 15997586 16001276 16004167 16004170 16004168 16006959 16016028 16018286 16018285 16027068 16034363 16038606 16038608 16042040 16043100 16051041 16052300 16056892 16081629 16089006 16107354 16121844 16124176 16124177 16124175 16124174 16124178 16142019 16142717 16147368 16150604 16150317 16154380 16154381 16179910 16185906 16186402 16186403 16188916 16188917 16189876 16191858 16191855 16192478 16192476 16198735 16205805 16205708 16210899 16211121 16211303 16211474 16216310 16216322 16216171 16216317 16216324 16216170 16217014 16217009 16217010 16217006 16222804 16229923 16234971 16234972 16234970 16234973 16234969 16235009 16236311 16238237 16238264 16239968 16247326 16253283 16262739 16267647 16273818 16273822 16277384 16280705 16282121 16282137 16282082 16283296 16287656 16291326 16292340 16294019 16295348 16295346 16297236 16297224 16299107 16300479 16309949 16315507 16317206 16317204 16317205 16317207 16319700 16319670 16322458 16322446 16323719 16327551 16335942 16337405 16338265 16338264 16344600 16344608 16349184 16349205 16354606 16380050 16381506 16381558 16411952 16411951 16412194 16413752 16413747 16415153 16415200 16415590 16416557 16416531 16418522 16418188 16418187 16418507 16423221 16425773 16426437 16433986 16444194 16445004 16444237 16445017 16460539 16461440 16460710 16460551 16468172 16468090 16468208 16468173 16468174 16469932 16474654 16479163 16484107 16487985 16490699 16507895 16507875 16529195 16538278 16550545 16554103 16554102 16554100 16554079 16582605 16585680 16585665 16585669 16585576 16585655 16595099 16595093 16601179 16627555 16626472 16627561 16626460 16630815 16641357 16664753 16672435 16685055 16685063 16706784 16706834 16712895 16719658 16719611 16719695 16755235 16755194 16764093 16767178 16769446 16773194 16785716 16785719 16790736 16808348 16808370 16808330 16811697 16826563 16832646 16832644 16832647 16843563 16881356 16907911. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0672-2025 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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      "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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