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  "name": "Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197",
  "description": "FDA recall Z-0482-2025 — ICU Medical, Inc. is recalling Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197 (Devices, Class I). 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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0482-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ICU Medical, Inc."
    }
  },
  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0482-2025/enforcement-record",
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      "name": "FDA recall Z-0482-2025: ICU Medical, Inc. is recalling Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197",
      "text": "The FDA logged enforcement record Z-0482-2025: ICU Medical, Inc. is voluntarily recalling Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems:  Plum 360\" Infusion System, Pump List Number\t30010; Plum A+ & Plum A+3\" Infusion Systems, Pump List Numbers:  11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197 — reason: ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems.  Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-22. Affected lots/codes: All batteries WITHOUT the following information on the label:  1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery):  W2401xxxx - W2406xxx. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "SourceCitation",
        "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-0482-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-0482-2025&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-0482-2025/fda-classification",
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      "name": "FDA classified recall Z-0482-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I",
        "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-0482-2025&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-0482-2025/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.",
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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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      "name": "FDA recall details — Z-0482-2025",
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            "Value": "Z-0482-2025",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
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          "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": "ICU Medical, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems.  Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-10-22",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "All batteries WITHOUT the following information on the label:  1) ICU Medlcal Test Label, 2) CE Mark, and WITH a Date code (yellow label found on side of battery):  W2401xxxx - W2406xxx",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay.",
            "Status": "recorded"
          }
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