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  "name": "BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide",
  "description": "FDA recall Z-0430-2026 — CareFusion 303, Inc. is recalling BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide",
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      "name": "CareFusion 303, Inc."
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      "name": "FDA recall Z-0430-2026: CareFusion 303, Inc. is recalling BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide",
      "text": "The FDA logged enforcement record Z-0430-2026: CareFusion 303, Inc. is voluntarily recalling BD Alaris infusion Pump Module 8100, REF: 8100;   KIT, BEZEL ASSY 8100BD, REF: 49000437;  KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270.    Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide — reason: If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-17. Affected lots/codes: All Alaris Pump Modules distributed after June 19, 2004.   REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0430-2026 as Class I",
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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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            "Value": "If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.",
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