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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0349-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog #  10062818;   BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog #  10821753;   BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog #  11171447;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  11426964;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog #  11532269;   BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter  Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog #  11613191;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  10015861A;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog #  22000-B007T;  BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog #  2202-0007;  BD AlarisTM Pump Infusion Set, Catalog #  2204-0007;   BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog #  2206-0007;  BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  2260-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22600-0007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22602-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22603-B007T;   BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog #  24001-0007;   BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog #  2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog #  24301-0007T;   BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog #  2441-0007;   BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog #  2450-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  24600-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  24601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog #  2465-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog #  2466-0007.",
  "description": "FDA recall Z-0349-2024 — Becton Dickinson & Company is recalling BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog #  10062818;   BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog #  10821753;   BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog #  11171447;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  11426964;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog #  11532269;   BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter  Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog #  11613191;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  10015861A;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog #  22000-B007T;  BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog #  2202-0007;  BD AlarisTM Pump Infusion Set, Catalog #  2204-0007;   BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog #  2206-0007;  BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  2260-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22600-0007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22602-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22603-B007T;   BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog #  24001-0007;   BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog #  2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog #  24301-0007T;   BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog #  2441-0007;   BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog #  2450-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  24600-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  24601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog #  2465-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog #  2466-0007. (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.",
  "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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0349-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog #  10062818;   BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog #  10821753;   BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog #  11171447;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  11426964;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog #  11532269;   BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter  Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog #  11613191;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  10015861A;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog #  22000-B007T;  BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog #  2202-0007;  BD AlarisTM Pump Infusion Set, Catalog #  2204-0007;   BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog #  2206-0007;  BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  2260-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22600-0007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22602-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22603-B007T;   BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog #  24001-0007;   BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog #  2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog #  24301-0007T;   BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog #  2441-0007;   BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog #  2450-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  24600-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  24601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog #  2465-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog #  2466-0007.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Becton Dickinson & Company"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0349-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0349-2024: Becton Dickinson & Company is recalling BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog #  10062818;   BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog #  10821753;   BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog #  11171447;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  11426964;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog #  11532269;   BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter  Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog #  11613191;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  10015861A;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog #  22000-B007T;  BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog #  2202-0007;  BD AlarisTM Pump Infusion Set, Catalog #  2204-0007;   BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog #  2206-0007;  BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  2260-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22600-0007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22602-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22603-B007T;   BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog #  24001-0007;   BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog #  2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog #  24301-0007T;   BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog #  2441-0007;   BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog #  2450-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  24600-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  24601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog #  2465-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog #  2466-0007.",
      "text": "The FDA logged enforcement record Z-0349-2024: Becton Dickinson & Company is voluntarily recalling BD Alaris Pump infusion sets (Product Name, Catalog #)    BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog #  10010483;   BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010453;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog #  10010454;   BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  10013072;   BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog #  10013361;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  10013890;   BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog #  10015012;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog #  10015862;   BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog #  10062818;   BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog #  10821753;   BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog #  11171447;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  11426964;   BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog #  11532269;   BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter  Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog #  11613191;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  10015861A;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog #  22000-B007T;  BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog #  2202-0007;  BD AlarisTM Pump Infusion Set, Catalog #  2204-0007;   BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog #  2206-0007;  BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog #  2260-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22600-0007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22602-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog #  22603-B007T;   BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog #  24001-0007;   BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog #  2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog #  24301-0007T;   BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog #  2441-0007;   BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog #  2450-0500;   BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog #  24600-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog #  24601-B007T;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog #  2465-0007;   BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog #  2466-0007. — reason: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-11. Affected lots/codes: UDI-DI:  10885403232602, Catalog #  10010483;  UDI-DI:  07613203021135, Catalog #  10010453;  UDI-DI:  07613203015806, Catalog #  10010454;  UDI-DI:  07613203021210, Catalog #  10013072;  UDI-DI:  10885403221965, Catalog #  10013361;  UDI-DI:  10885403232268, Catalog #  10013890;  UDI-DI:  10885403233951, Catalog #  10015012;  UDI-DI:  10885403221866, Catalog #  10015862;  UDI-DI:  07613203019668, Catalog #  10062818;  UDI-DI:  07613203019187, Catalog #  10821753;  UDI-DI:  07613203021234, Catalog #  11171447;  UDI-DI:  10885403232367, Catalog #  11426964;  UDI-DI:  10885403232343, Catalog #  11532269;  UDI-DI:  10885403276026, Catalog #  11613191;  UDI-DI:  10885403232626, Catalog #  10015861A;  UDI-DI:  10885403245022, Catalog #  22000-B007T;  UDI-DI:  10885403274039, Catalog #  2202-0007;  UDI-DI:  10885403199363, Catalog #  2204-0007;  UDI-DI:  07613203019224, Catalog #  2206-0007;  UDI-DI:  07613203012591, Catalog #  2260-0500;  UDI-DI:  10885403239595, Catalog #  22600-0007T;  UDI-DI:  10885403240966, Catalog #  22601-B007T;  UDI-DI:  10885403240935, Catalog #  22602-B007T;  UDI-DI:  10885403240942, Catalog #  22603-B007T;  UDI-DI:  10885403238666, Catalog #  24001-0007;  UDI-DI:  10885403232473, Catalog #  2403-0007;  UDI-DI:  10885403223198, Catalog #  24301-0007T;  UDI-DI:  10885403235047, Catalog #  2441-0007;  UDI-DI:  10885403235115, Catalog #  2450-0500; ; UDI-DI:  10885403241970, Catalog #  24600-0007; UDI-DI:  10885403240959, Catalog #  24601-B007T;  UDI-DI:  10885403221941, Catalog #  2465-0007;  UDI-DI:  10885403221958, Catalog #  2466-0007.  All lots, expiration date thru July 31, 2026.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-0349-2024&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-0349-2024&lang=eng"
        }
      },
      "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-0349-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0349-2024 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",
      "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-0349-2024&lang=eng",
        "value": "Class II",
        "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-0349-2024&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-0349-2024/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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0349-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0349-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "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": "Becton Dickinson & Company",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-10-11",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI:  10885403232602, Catalog #  10010483;  UDI-DI:  07613203021135, Catalog #  10010453;  UDI-DI:  07613203015806, Catalog #  10010454;  UDI-DI:  07613203021210, Catalog #  10013072;  UDI-DI:  10885403221965, Catalog #  10013361;  UDI-DI:  10885403232268, Catalog #  10013890;  UDI-DI:  10885403233951, Catalog #  10015012;  UDI-DI:  10885403221866, Catalog #  10015862;  UDI-DI:  07613203019668, Catalog #  10062818;  UDI-DI:  07613203019187, Catalog #  10821753;  UDI-DI:  07613203021234, Catalog #  11171447;  UDI-DI:  10885403232367, Catalog #  11426964;  UDI-DI:  10885403232343, Catalog #  11532269;  UDI-DI:  10885403276026, Catalog #  11613191;  UDI-DI:  10885403232626, Catalog #  10015861A;  UDI-DI:  10885403245022, Catalog #  22000-B007T;  UDI-DI:  10885403274039, Catalog #  2202-0007;  UDI-DI:  10885403199363, Catalog #  2204-0007;  UDI-DI:  07613203019224, Catalog #  2206-0007;  UDI-DI:  07613203012591, Catalog #  2260-0500;  UDI-DI:  10885403239595, Catalog #  22600-0007T;  UDI-DI:  10885403240966, Catalog #  22601-B007T;  UDI-DI:  10885403240935, Catalog #  22602-B007T;  UDI-DI:  10885403240942, Catalog #  22603-B007T;  UDI-DI:  10885403238666, Catalog #  24001-0007;  UDI-DI:  10885403232473, Catalog #  2403-0007;  UDI-DI:  10885403223198, Catalog #  24301-0007T;  UDI-DI:  10885403235047, Catalog #  2441-0007;  UDI-DI:  10885403235115, Catalog #  2450-0500; ; UDI-DI:  10885403241970, Catalog #  24600-0007; UDI-DI:  10885403240959, Catalog #  24601-B007T;  UDI-DI:  10885403221941, Catalog #  2465-0007;  UDI-DI:  10885403221958, Catalog #  2466-0007.  All lots, expiration date thru July 31, 2026.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}