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  "name": "BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;    REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;    REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;    REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;    REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;    REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;    REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;    REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M    REF: 11419365, BD Alaris\" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite\" Y-sites    REF: 10813621,  BD Alaris\" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 2423-0007, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 10015896, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite\" Y-sites    REF: 24010-0007T, BD Alaris\" Pump Infusion Set, Bonded Texium\", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite\" Y-sites    REF: 10010483, BD Alaris\" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing    REF: 2403-0007, BD Alaris\" Pump Infusion Set, Half Set, SmartSite\" Y-site    REF: 24301-0007T, BD Alaris\" Pump Infusion Set, SmartSite\" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium\" Closed Male Luer with Priming Cap, SmartSite\" Y-site",
  "description": "FDA recall Z-2180-2025 — CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;    REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;    REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;    REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;    REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;    REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;    REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;    REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M    REF: 11419365, BD Alaris\" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite\" Y-sites    REF: 10813621,  BD Alaris\" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 2423-0007, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 10015896, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite\" Y-sites    REF: 24010-0007T, BD Alaris\" Pump Infusion Set, Bonded Texium\", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite\" Y-sites    REF: 10010483, BD Alaris\" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing    REF: 2403-0007, BD Alaris\" Pump Infusion Set, Half Set, SmartSite\" Y-site    REF: 24301-0007T, BD Alaris\" Pump Infusion Set, SmartSite\" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium\" Closed Male Luer with Priming Cap, SmartSite\" Y-site (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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    "@type": "schema:MedicalDevice",
    "name": "BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;    REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;    REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;    REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;    REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;    REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;    REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;    REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M    REF: 11419365, BD Alaris\" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite\" Y-sites    REF: 10813621,  BD Alaris\" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 2423-0007, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 10015896, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite\" Y-sites    REF: 24010-0007T, BD Alaris\" Pump Infusion Set, Bonded Texium\", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite\" Y-sites    REF: 10010483, BD Alaris\" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing    REF: 2403-0007, BD Alaris\" Pump Infusion Set, Half Set, SmartSite\" Y-site    REF: 24301-0007T, BD Alaris\" Pump Infusion Set, SmartSite\" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium\" Closed Male Luer with Priming Cap, SmartSite\" Y-site",
    "manufacturer": {
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      "name": "CareFusion 303, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2180-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2180-2025: CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;    REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;    REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;    REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;    REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;    REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;    REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;    REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M    REF: 11419365, BD Alaris\" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite\" Y-sites    REF: 10813621,  BD Alaris\" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 2423-0007, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 10015896, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite\" Y-sites    REF: 24010-0007T, BD Alaris\" Pump Infusion Set, Bonded Texium\", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite\" Y-sites    REF: 10010483, BD Alaris\" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing    REF: 2403-0007, BD Alaris\" Pump Infusion Set, Half Set, SmartSite\" Y-site    REF: 24301-0007T, BD Alaris\" Pump Infusion Set, SmartSite\" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium\" Closed Male Luer with Priming Cap, SmartSite\" Y-site",
      "text": "The FDA logged enforcement record Z-2180-2025: CareFusion 303, Inc. is voluntarily recalling BD Alaris Pump Infusion Sets    REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV;    REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV;    REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D;    REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV;    REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M;    REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV;    REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV;    REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M;    REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV;    REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV;    REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M;    REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV;    REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV;    REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M;    REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M;    REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M    REF: 11419365, BD Alaris\" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite\" Y-sites    REF: 10813621,  BD Alaris\" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 2423-0007, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite\" Y-sites    REF: 10015896, BD Alaris\" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite\" Y-sites    REF: 24010-0007T, BD Alaris\" Pump Infusion Set, Bonded Texium\", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite\" Y-sites    REF: 10010483, BD Alaris\" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing    REF: 2403-0007, BD Alaris\" Pump Infusion Set, Half Set, SmartSite\" Y-site    REF: 24301-0007T, BD Alaris\" Pump Infusion Set, SmartSite\" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium\" Closed Male Luer with Priming Cap, SmartSite\" Y-site — 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 2025-07-08. Affected lots/codes: REF: 10013186/ UDI:  07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
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        "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-2180-2025&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-2180-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2180-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2180-2025 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2180-2025&lang=eng",
        "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-2180-2025&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-2180-2025/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "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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        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "CareFusion 303, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-07-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF: 10013186/ UDI:  07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide Distribution to states of: AK\tAL\tAR\tAS\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tGU\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMP\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVT\tWA\tWI\tWV\tWY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}