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  "name": "BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite\" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock",
  "description": "FDA recall Z-0035-2026 — CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite\" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock (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:MedicalDevice",
    "name": "BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite\" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock",
    "manufacturer": {
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      "name": "CareFusion 303, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0035-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0035-2026: CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite\" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock",
      "text": "The FDA logged enforcement record Z-0035-2026: CareFusion 303, Inc. is voluntarily recalling BD Alaris Pump Infusion Sets for the following reference numbers:   C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite  Y-Site  10015414, 180 Micron Filter  2447-0007,  Ball Valve SmartSite Port (Burette) 2 SmartSites  Y-Sites  24201-0007, 2 SmartSite  Y-sites  10012645, Back Check Valve, Non-vented, SmartSite  Y-site    2426-0500, Back Check Valve, 3 SmartSite  Y-sites  2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite  Y-sites  11522558, Ball Valve, Back Check Valve, 3 SmartSite  Y-sites  2410-0500, 2 SmartSite  Y-Sites  2232-0007, 0.2 Micron Filter  11613191, 0.2 Micron Filter, Ball Valve, SmartSite\" Port (Burette), 2 SmartSite  Y-sites  10012144, 3 SmartSite Y-Sites, Check Valve  10013034, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 4-way Stopcock  10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site  11582773, 3 SmartSite  Y-Sites, Check Valve, 2-Ganged 3-way Stopcock — reason: Infusion pump module used with compatible  pump infusion sets  may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-11. Affected lots/codes: All Lots/ UDI: C24101E - 10885403235528, 10015414 - 10885403233999, 2447-0007 - 10885403235078, 24201-0007 - 10885403476341, 10012645 - 10885403233753, 2426-0500 - 7613203020992, 11522558 - 10885403232305, 2410-0500 - 7613203012492, 2232-0007 - 10885403463969, 11613191 - 10885403276026, 10012144 - 7613203021159, 10013034 - 10885403232312, 10013037 - 10885403233784, 11582773 - 10885403239588. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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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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      "name": "FDA classified recall Z-0035-2026 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",
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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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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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": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "CareFusion 303, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Infusion pump module used with compatible  pump infusion sets  may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-09-11",
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            "Field": "Lot/code info",
            "Value": "All Lots/ UDI: C24101E - 10885403235528, 10015414 - 10885403233999, 2447-0007 - 10885403235078, 24201-0007 - 10885403476341, 10012645 - 10885403233753, 2426-0500 - 7613203020992, 11522558 - 10885403232305, 2410-0500 - 7613203012492, 2232-0007 - 10885403463969, 11613191 - 10885403276026, 10012144 - 7613203021159, 10013034 - 10885403232312, 10013037 - 10885403233784, 11582773 - 10885403239588",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "US: Nationwide  OUS: United Arab Emirates Australia Belgium Bahrain\t Botswana\t Canada\tSwitzerland\t China\t France\t United Kingdom Gibraltar\t Israel\tIndia\t Kuwait\t Mexico\tMalaysia\t Netherlands\t New Zealand\t Philippines\t Pakistan\t Qatar\t Saudi Arabia\t Singapore\t Taiwan, Province of China\t South Africa",
            "Status": "recorded"
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