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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2255-2024.jsonld",
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  "name": "BD Pyxis, Name/REF:   MEDBANK MINI 1FH-1FM/ 169-137,  MEDBANK MINI 1FH-2HH MEDPASS/ 169-151,  MEDBANK MINI 1HH-1FH-1HM/ 169-101,  MEDBANK MINI 1HH-1HM-1FM/ 169-102,  MEDBANK MINI 1HH-3HM/ 169-103,  MEDBANK MINI 2FH/ 169-104,  MEDBANK MINI 2FM/ 169-105,  MEDBANK MINI 2HH-1FH/ 169-106,  MEDBANK MINI 2HH-1FM/ 169-107,  MEDBANK MINI 2HH-1FM MEDPASS/ 169-152,  MEDBANK MINI 2HH-2HM/ 169-108,  MEDBANK MINI 2HM-1FM/ 169-109,  MEDBANK MINI 3HH-1FG/ 169-110,  MEDBANK MINI 3HH-1HM/ 169-111,  MEDBANK MINI 4HH/ 169-112,  MEDBANK MINI 4HH MEDPASS/ 169-150,  MEDBANK MINI 4HM/ 169-113,  MEDBANK MINI CR-2HH-1FH-P/ 169-114,  MEDBANK MINI CR-4HH-P/ 169-115,  MB MINI MAIN CR/ 169-163,  MB MINI MAIN W/CUBIE DRWS/ 169-159,  MB MINI MAIN W/FH FALSE DRW/ 169-162,  MB MINI MAIN W/HH FALSE DRW/ 169-161,  MB MINI MAIN W/MATRIX DRWS\t/ 169-160,  MB MINI MAIN W/MP/ 169-164      Used with the following user guides:  BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989),  BD Pyxis MedBank Cabinet User Guide (DIR 10000414987),  BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)",
  "description": "FDA recall Z-2255-2024 — CareFusion 303, Inc. is recalling BD Pyxis, Name/REF:   MEDBANK MINI 1FH-1FM/ 169-137,  MEDBANK MINI 1FH-2HH MEDPASS/ 169-151,  MEDBANK MINI 1HH-1FH-1HM/ 169-101,  MEDBANK MINI 1HH-1HM-1FM/ 169-102,  MEDBANK MINI 1HH-3HM/ 169-103,  MEDBANK MINI 2FH/ 169-104,  MEDBANK MINI 2FM/ 169-105,  MEDBANK MINI 2HH-1FH/ 169-106,  MEDBANK MINI 2HH-1FM/ 169-107,  MEDBANK MINI 2HH-1FM MEDPASS/ 169-152,  MEDBANK MINI 2HH-2HM/ 169-108,  MEDBANK MINI 2HM-1FM/ 169-109,  MEDBANK MINI 3HH-1FG/ 169-110,  MEDBANK MINI 3HH-1HM/ 169-111,  MEDBANK MINI 4HH/ 169-112,  MEDBANK MINI 4HH MEDPASS/ 169-150,  MEDBANK MINI 4HM/ 169-113,  MEDBANK MINI CR-2HH-1FH-P/ 169-114,  MEDBANK MINI CR-4HH-P/ 169-115,  MB MINI MAIN CR/ 169-163,  MB MINI MAIN W/CUBIE DRWS/ 169-159,  MB MINI MAIN W/FH FALSE DRW/ 169-162,  MB MINI MAIN W/HH FALSE DRW/ 169-161,  MB MINI MAIN W/MATRIX DRWS\t/ 169-160,  MB MINI MAIN W/MP/ 169-164      Used with the following user guides:  BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989),  BD Pyxis MedBank Cabinet User Guide (DIR 10000414987),  BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990) (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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    "@type": "schema:MedicalDevice",
    "name": "BD Pyxis, Name/REF:   MEDBANK MINI 1FH-1FM/ 169-137,  MEDBANK MINI 1FH-2HH MEDPASS/ 169-151,  MEDBANK MINI 1HH-1FH-1HM/ 169-101,  MEDBANK MINI 1HH-1HM-1FM/ 169-102,  MEDBANK MINI 1HH-3HM/ 169-103,  MEDBANK MINI 2FH/ 169-104,  MEDBANK MINI 2FM/ 169-105,  MEDBANK MINI 2HH-1FH/ 169-106,  MEDBANK MINI 2HH-1FM/ 169-107,  MEDBANK MINI 2HH-1FM MEDPASS/ 169-152,  MEDBANK MINI 2HH-2HM/ 169-108,  MEDBANK MINI 2HM-1FM/ 169-109,  MEDBANK MINI 3HH-1FG/ 169-110,  MEDBANK MINI 3HH-1HM/ 169-111,  MEDBANK MINI 4HH/ 169-112,  MEDBANK MINI 4HH MEDPASS/ 169-150,  MEDBANK MINI 4HM/ 169-113,  MEDBANK MINI CR-2HH-1FH-P/ 169-114,  MEDBANK MINI CR-4HH-P/ 169-115,  MB MINI MAIN CR/ 169-163,  MB MINI MAIN W/CUBIE DRWS/ 169-159,  MB MINI MAIN W/FH FALSE DRW/ 169-162,  MB MINI MAIN W/HH FALSE DRW/ 169-161,  MB MINI MAIN W/MATRIX DRWS\t/ 169-160,  MB MINI MAIN W/MP/ 169-164      Used with the following user guides:  BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989),  BD Pyxis MedBank Cabinet User Guide (DIR 10000414987),  BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "CareFusion 303, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2255-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2255-2024: CareFusion 303, Inc. is recalling BD Pyxis, Name/REF:   MEDBANK MINI 1FH-1FM/ 169-137,  MEDBANK MINI 1FH-2HH MEDPASS/ 169-151,  MEDBANK MINI 1HH-1FH-1HM/ 169-101,  MEDBANK MINI 1HH-1HM-1FM/ 169-102,  MEDBANK MINI 1HH-3HM/ 169-103,  MEDBANK MINI 2FH/ 169-104,  MEDBANK MINI 2FM/ 169-105,  MEDBANK MINI 2HH-1FH/ 169-106,  MEDBANK MINI 2HH-1FM/ 169-107,  MEDBANK MINI 2HH-1FM MEDPASS/ 169-152,  MEDBANK MINI 2HH-2HM/ 169-108,  MEDBANK MINI 2HM-1FM/ 169-109,  MEDBANK MINI 3HH-1FG/ 169-110,  MEDBANK MINI 3HH-1HM/ 169-111,  MEDBANK MINI 4HH/ 169-112,  MEDBANK MINI 4HH MEDPASS/ 169-150,  MEDBANK MINI 4HM/ 169-113,  MEDBANK MINI CR-2HH-1FH-P/ 169-114,  MEDBANK MINI CR-4HH-P/ 169-115,  MB MINI MAIN CR/ 169-163,  MB MINI MAIN W/CUBIE DRWS/ 169-159,  MB MINI MAIN W/FH FALSE DRW/ 169-162,  MB MINI MAIN W/HH FALSE DRW/ 169-161,  MB MINI MAIN W/MATRIX DRWS\t/ 169-160,  MB MINI MAIN W/MP/ 169-164      Used with the following user guides:  BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989),  BD Pyxis MedBank Cabinet User Guide (DIR 10000414987),  BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990)",
      "text": "The FDA logged enforcement record Z-2255-2024: CareFusion 303, Inc. is voluntarily recalling BD Pyxis, Name/REF:   MEDBANK MINI 1FH-1FM/ 169-137,  MEDBANK MINI 1FH-2HH MEDPASS/ 169-151,  MEDBANK MINI 1HH-1FH-1HM/ 169-101,  MEDBANK MINI 1HH-1HM-1FM/ 169-102,  MEDBANK MINI 1HH-3HM/ 169-103,  MEDBANK MINI 2FH/ 169-104,  MEDBANK MINI 2FM/ 169-105,  MEDBANK MINI 2HH-1FH/ 169-106,  MEDBANK MINI 2HH-1FM/ 169-107,  MEDBANK MINI 2HH-1FM MEDPASS/ 169-152,  MEDBANK MINI 2HH-2HM/ 169-108,  MEDBANK MINI 2HM-1FM/ 169-109,  MEDBANK MINI 3HH-1FG/ 169-110,  MEDBANK MINI 3HH-1HM/ 169-111,  MEDBANK MINI 4HH/ 169-112,  MEDBANK MINI 4HH MEDPASS/ 169-150,  MEDBANK MINI 4HM/ 169-113,  MEDBANK MINI CR-2HH-1FH-P/ 169-114,  MEDBANK MINI CR-4HH-P/ 169-115,  MB MINI MAIN CR/ 169-163,  MB MINI MAIN W/CUBIE DRWS/ 169-159,  MB MINI MAIN W/FH FALSE DRW/ 169-162,  MB MINI MAIN W/HH FALSE DRW/ 169-161,  MB MINI MAIN W/MATRIX DRWS\t/ 169-160,  MB MINI MAIN W/MP/ 169-164      Used with the following user guides:  BD Pyxis CUBIE Replenishment Station User Guide (DIR 10000414989),  BD Pyxis MedBank Cabinet User Guide (DIR 10000414987),  BD Pyxis MedBank Installation and Upgrade Guide (DIR 10000414990) — reason: Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-13. Affected lots/codes: UDI-DI: 10885403512544. Devices Manufactured November 15, 2012 - July, 25 2023  User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2255-2024&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-2255-2024&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-2255-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2255-2024 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",
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        "value": "Class II",
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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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "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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      "name": "FDA recall details — Z-2255-2024",
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            "Value": "Z-2255-2024",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "CareFusion 303, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-13",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 10885403512544. Devices Manufactured November 15, 2012 - July, 25 2023  User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS, IL, FL, OK, OH, TN, GA, NM, NV, NE, TX, NC, KY, WI, SC, IA, MT, SD, VA, NJ, PA, AK, MS, MI, WA, UT, ND, MA, MN, OR, IN, WV, AL, ID, LA, CT, WY, MD, NH, AR, HI, DC.",
            "Status": "recorded"
          }
        }
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}