{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2995-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline convenience kits labeled as:   1) PERMANENT PACING, Pack Number 00-400361J ;  2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;  3) PACEMAKER TRAY, Pack Number 00-401521F ;  4) FEMORAL PACK, Pack Number 00-401525G ;  5) CARDIAC CATH PACK , Pack Number 00-401561K ;  6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;  7) LEFT HEART TRAY , Pack Number 00-401880I ;  8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;  9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;  10) ADVANTEC-MLD, Pack Number 00-500510D ;  11) ADVANTEC-MLD, Pack Number 00-500510F ;  12) KIT ANGIO CSTM-WALKER, Pack Number 129969;  13) DIAGNOSTIC KIT, Pack Number 147943;  14) MSC - CRESCENT MEDICAL, Pack Number 149155;  15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;  16) OPEN HEART CDS, Pack Number CDS840015AK;  17) OPEN HEART CDS, Pack Number CDS840015AL;  18) OPEN HEART CDS, Pack Number CDS840015AM;  19) OPEN HEART CDS, Pack Number CDS840015AN;  20) OPEN HEART CDS, Pack Number CDS840015AO;  21) OPEN HEART CDS, Pack Number CDS840015AP;  22) OPEN HEART CDS, Pack Number CDS840015AQ;  23) OPEN HEART CDS, Pack Number CDS840015AQ;  24) OPEN HEART CDS, Pack Number CDS840016AD;  25) OPEN HEART CDS, Pack Number CDS840016AD;  26) OPEN HEART CDS, Pack Number CDS840023R ;  27) OPEN HEART CDS, Pack Number CDS840023S ;  28) OPEN HEART CDS, Pack Number CDS840023T ;  29) AAA CDS , Pack Number CDS840076AC;  30) OFF PUMP CABG CDS , Pack Number CDS840087AB;  31) OFF PUMP CABG CDS , Pack Number CDS840087AD;  32) OFF PUMP CABG CDS , Pack Number CDS840087AF;  33) OFF PUMP CABG CDS , Pack Number CDS840087AG;  34) OFF PUMP CABG CDS , Pack Number CDS840087AI;  35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;  36) OFF PUMP CABG CDS , Pack Number CDS840087AK;  37) OFF PUMP CABG CDS , Pack Number CDS840087AL;  38) OPEN HEART CDS, Pack Number CDS840094L ;  39) OPEN HEART CDS, Pack Number CDS840094M ;  40) OPEN HEART CDS, Pack Number CDS840094N ;  41) OPEN HEART CDS, Pack Number CDS840094P ;  42) OPEN HEART CDS, Pack Number CDS840108J ;  43) OPEN HEART CDS, Pack Number CDS840108K ;  44) OPEN HEART CDS, Pack Number CDS840132N ;  45) OPEN HEART CDS, Pack Number CDS840132O ;  46) OPEN HEART CDS, Pack Number CDS840144O ;  47) OPEN HEART CDS, Pack Number CDS840144P ;  48) OPEN HEART CDS, Pack Number CDS840144Q ;  49) OPEN HEART CDS, Pack Number CDS840144Q ;  50) OPEN HEART CDS, Pack Number CDS840145S ;  51) OPEN HEART CDS, Pack Number CDS840145T ;  52) OPEN HEART CDS, Pack Number CDS840145U ;  53) OPEN HEART, Pack Number CDS840150R ;  54) OPEN HEART, Pack Number CDS840150S ;  55) OPEN HEART, Pack Number CDS840150T ;  56) OPEN HEART, Pack Number CDS840150U ;  57) OPEN HEART, Pack Number CDS840150V ;  58) PACEMAKER CDS , Pack Number CDS840162S ;  59) PACEMAKER CDS , Pack Number CDS840162T ;  60) PACEMAKER CDS , Pack Number CDS840162U ;  61) PACEMAKER CDS , Pack Number CDS840162V ;  62) OPEN HEART CDS, Pack Number CDS840171AA;  63) OPEN HEART CDS, Pack Number CDS840171AB;  64) OPEN HEART CDS, Pack Number CDS840171AC;  65) OPEN HEART CDS, Pack Number CDS840171AD;  66) HEART CDS , Pack Number CDS840179M ;  67) HEART CDS, Pack Number CDS840179M ;  68) MINOR VASCULAR PACK , Pack Number CDS840184M ;  69) MINOR VASCULAR PACK , Pack Number CDS840184N ;  70) MINOR VASCULAR PACK , Pack Number CDS840184O ;  71) MINOR VASCULAR PACK, Pack Number CDS840184P;  72) OPEN HEART PACK , Pack Number CDS840185S ;  73) OPEN HEART PACK , Pack Number CDS840185T ;  74) OPEN HEART PACK , Pack Number CDS840185U ;  75) OPEN HEART PACK , Pack Number CDS840185V ;  76) OPEN HEART PACK , Pack Number CDS840185W ;  77) VALVE PACK, Pack Number CDS840187S ;  78) VALVE PACK, Pack Number CDS840187T ;  79) OPEN HEART, Pack Number CDS840189R ;  80) MAJOR VASCULAR, Pack Number CDS840195T ;  81) MAJOR VASCULAR, Pack Number CDS840195U ;  82) CABG-LF , Pack Number CDS840231Q ;  83) CABG-LF , Pack Number CDS840231R ;  84) CABG-LF , Pack Number CDS840231S ;  85) CABG-LF , Pack Number CDS840231T ;  86) MAJOR VASCU",
  "description": "FDA recall Z-2995-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits labeled as:   1) PERMANENT PACING, Pack Number 00-400361J ;  2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;  3) PACEMAKER TRAY, Pack Number 00-401521F ;  4) FEMORAL PACK, Pack Number 00-401525G ;  5) CARDIAC CATH PACK , Pack Number 00-401561K ;  6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;  7) LEFT HEART TRAY , Pack Number 00-401880I ;  8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;  9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;  10) ADVANTEC-MLD, Pack Number 00-500510D ;  11) ADVANTEC-MLD, Pack Number 00-500510F ;  12) KIT ANGIO CSTM-WALKER, Pack Number 129969;  13) DIAGNOSTIC KIT, Pack Number 147943;  14) MSC - CRESCENT MEDICAL, Pack Number 149155;  15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;  16) OPEN HEART CDS, Pack Number CDS840015AK;  17) OPEN HEART CDS, Pack Number CDS840015AL;  18) OPEN HEART CDS, Pack Number CDS840015AM;  19) OPEN HEART CDS, Pack Number CDS840015AN;  20) OPEN HEART CDS, Pack Number CDS840015AO;  21) OPEN HEART CDS, Pack Number CDS840015AP;  22) OPEN HEART CDS, Pack Number CDS840015AQ;  23) OPEN HEART CDS, Pack Number CDS840015AQ;  24) OPEN HEART CDS, Pack Number CDS840016AD;  25) OPEN HEART CDS, Pack Number CDS840016AD;  26) OPEN HEART CDS, Pack Number CDS840023R ;  27) OPEN HEART CDS, Pack Number CDS840023S ;  28) OPEN HEART CDS, Pack Number CDS840023T ;  29) AAA CDS , Pack Number CDS840076AC;  30) OFF PUMP CABG CDS , Pack Number CDS840087AB;  31) OFF PUMP CABG CDS , Pack Number CDS840087AD;  32) OFF PUMP CABG CDS , Pack Number CDS840087AF;  33) OFF PUMP CABG CDS , Pack Number CDS840087AG;  34) OFF PUMP CABG CDS , Pack Number CDS840087AI;  35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;  36) OFF PUMP CABG CDS , Pack Number CDS840087AK;  37) OFF PUMP CABG CDS , Pack Number CDS840087AL;  38) OPEN HEART CDS, Pack Number CDS840094L ;  39) OPEN HEART CDS, Pack Number CDS840094M ;  40) OPEN HEART CDS, Pack Number CDS840094N ;  41) OPEN HEART CDS, Pack Number CDS840094P ;  42) OPEN HEART CDS, Pack Number CDS840108J ;  43) OPEN HEART CDS, Pack Number CDS840108K ;  44) OPEN HEART CDS, Pack Number CDS840132N ;  45) OPEN HEART CDS, Pack Number CDS840132O ;  46) OPEN HEART CDS, Pack Number CDS840144O ;  47) OPEN HEART CDS, Pack Number CDS840144P ;  48) OPEN HEART CDS, Pack Number CDS840144Q ;  49) OPEN HEART CDS, Pack Number CDS840144Q ;  50) OPEN HEART CDS, Pack Number CDS840145S ;  51) OPEN HEART CDS, Pack Number CDS840145T ;  52) OPEN HEART CDS, Pack Number CDS840145U ;  53) OPEN HEART, Pack Number CDS840150R ;  54) OPEN HEART, Pack Number CDS840150S ;  55) OPEN HEART, Pack Number CDS840150T ;  56) OPEN HEART, Pack Number CDS840150U ;  57) OPEN HEART, Pack Number CDS840150V ;  58) PACEMAKER CDS , Pack Number CDS840162S ;  59) PACEMAKER CDS , Pack Number CDS840162T ;  60) PACEMAKER CDS , Pack Number CDS840162U ;  61) PACEMAKER CDS , Pack Number CDS840162V ;  62) OPEN HEART CDS, Pack Number CDS840171AA;  63) OPEN HEART CDS, Pack Number CDS840171AB;  64) OPEN HEART CDS, Pack Number CDS840171AC;  65) OPEN HEART CDS, Pack Number CDS840171AD;  66) HEART CDS , Pack Number CDS840179M ;  67) HEART CDS, Pack Number CDS840179M ;  68) MINOR VASCULAR PACK , Pack Number CDS840184M ;  69) MINOR VASCULAR PACK , Pack Number CDS840184N ;  70) MINOR VASCULAR PACK , Pack Number CDS840184O ;  71) MINOR VASCULAR PACK, Pack Number CDS840184P;  72) OPEN HEART PACK , Pack Number CDS840185S ;  73) OPEN HEART PACK , Pack Number CDS840185T ;  74) OPEN HEART PACK , Pack Number CDS840185U ;  75) OPEN HEART PACK , Pack Number CDS840185V ;  76) OPEN HEART PACK , Pack Number CDS840185W ;  77) VALVE PACK, Pack Number CDS840187S ;  78) VALVE PACK, Pack Number CDS840187T ;  79) OPEN HEART, Pack Number CDS840189R ;  80) MAJOR VASCULAR, Pack Number CDS840195T ;  81) MAJOR VASCULAR, Pack Number CDS840195U ;  82) CABG-LF , Pack Number CDS840231Q ;  83) CABG-LF , Pack Number CDS840231R ;  84) CABG-LF , Pack Number CDS840231S ;  85) CABG-LF , Pack Number CDS840231T ;  86) MAJOR VASCU (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2995-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline convenience kits labeled as:   1) PERMANENT PACING, Pack Number 00-400361J ;  2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;  3) PACEMAKER TRAY, Pack Number 00-401521F ;  4) FEMORAL PACK, Pack Number 00-401525G ;  5) CARDIAC CATH PACK , Pack Number 00-401561K ;  6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;  7) LEFT HEART TRAY , Pack Number 00-401880I ;  8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;  9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;  10) ADVANTEC-MLD, Pack Number 00-500510D ;  11) ADVANTEC-MLD, Pack Number 00-500510F ;  12) KIT ANGIO CSTM-WALKER, Pack Number 129969;  13) DIAGNOSTIC KIT, Pack Number 147943;  14) MSC - CRESCENT MEDICAL, Pack Number 149155;  15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;  16) OPEN HEART CDS, Pack Number CDS840015AK;  17) OPEN HEART CDS, Pack Number CDS840015AL;  18) OPEN HEART CDS, Pack Number CDS840015AM;  19) OPEN HEART CDS, Pack Number CDS840015AN;  20) OPEN HEART CDS, Pack Number CDS840015AO;  21) OPEN HEART CDS, Pack Number CDS840015AP;  22) OPEN HEART CDS, Pack Number CDS840015AQ;  23) OPEN HEART CDS, Pack Number CDS840015AQ;  24) OPEN HEART CDS, Pack Number CDS840016AD;  25) OPEN HEART CDS, Pack Number CDS840016AD;  26) OPEN HEART CDS, Pack Number CDS840023R ;  27) OPEN HEART CDS, Pack Number CDS840023S ;  28) OPEN HEART CDS, Pack Number CDS840023T ;  29) AAA CDS , Pack Number CDS840076AC;  30) OFF PUMP CABG CDS , Pack Number CDS840087AB;  31) OFF PUMP CABG CDS , Pack Number CDS840087AD;  32) OFF PUMP CABG CDS , Pack Number CDS840087AF;  33) OFF PUMP CABG CDS , Pack Number CDS840087AG;  34) OFF PUMP CABG CDS , Pack Number CDS840087AI;  35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;  36) OFF PUMP CABG CDS , Pack Number CDS840087AK;  37) OFF PUMP CABG CDS , Pack Number CDS840087AL;  38) OPEN HEART CDS, Pack Number CDS840094L ;  39) OPEN HEART CDS, Pack Number CDS840094M ;  40) OPEN HEART CDS, Pack Number CDS840094N ;  41) OPEN HEART CDS, Pack Number CDS840094P ;  42) OPEN HEART CDS, Pack Number CDS840108J ;  43) OPEN HEART CDS, Pack Number CDS840108K ;  44) OPEN HEART CDS, Pack Number CDS840132N ;  45) OPEN HEART CDS, Pack Number CDS840132O ;  46) OPEN HEART CDS, Pack Number CDS840144O ;  47) OPEN HEART CDS, Pack Number CDS840144P ;  48) OPEN HEART CDS, Pack Number CDS840144Q ;  49) OPEN HEART CDS, Pack Number CDS840144Q ;  50) OPEN HEART CDS, Pack Number CDS840145S ;  51) OPEN HEART CDS, Pack Number CDS840145T ;  52) OPEN HEART CDS, Pack Number CDS840145U ;  53) OPEN HEART, Pack Number CDS840150R ;  54) OPEN HEART, Pack Number CDS840150S ;  55) OPEN HEART, Pack Number CDS840150T ;  56) OPEN HEART, Pack Number CDS840150U ;  57) OPEN HEART, Pack Number CDS840150V ;  58) PACEMAKER CDS , Pack Number CDS840162S ;  59) PACEMAKER CDS , Pack Number CDS840162T ;  60) PACEMAKER CDS , Pack Number CDS840162U ;  61) PACEMAKER CDS , Pack Number CDS840162V ;  62) OPEN HEART CDS, Pack Number CDS840171AA;  63) OPEN HEART CDS, Pack Number CDS840171AB;  64) OPEN HEART CDS, Pack Number CDS840171AC;  65) OPEN HEART CDS, Pack Number CDS840171AD;  66) HEART CDS , Pack Number CDS840179M ;  67) HEART CDS, Pack Number CDS840179M ;  68) MINOR VASCULAR PACK , Pack Number CDS840184M ;  69) MINOR VASCULAR PACK , Pack Number CDS840184N ;  70) MINOR VASCULAR PACK , Pack Number CDS840184O ;  71) MINOR VASCULAR PACK, Pack Number CDS840184P;  72) OPEN HEART PACK , Pack Number CDS840185S ;  73) OPEN HEART PACK , Pack Number CDS840185T ;  74) OPEN HEART PACK , Pack Number CDS840185U ;  75) OPEN HEART PACK , Pack Number CDS840185V ;  76) OPEN HEART PACK , Pack Number CDS840185W ;  77) VALVE PACK, Pack Number CDS840187S ;  78) VALVE PACK, Pack Number CDS840187T ;  79) OPEN HEART, Pack Number CDS840189R ;  80) MAJOR VASCULAR, Pack Number CDS840195T ;  81) MAJOR VASCULAR, Pack Number CDS840195U ;  82) CABG-LF , Pack Number CDS840231Q ;  83) CABG-LF , Pack Number CDS840231R ;  84) CABG-LF , Pack Number CDS840231S ;  85) CABG-LF , Pack Number CDS840231T ;  86) MAJOR VASCU",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2995-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2995-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits labeled as:   1) PERMANENT PACING, Pack Number 00-400361J ;  2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;  3) PACEMAKER TRAY, Pack Number 00-401521F ;  4) FEMORAL PACK, Pack Number 00-401525G ;  5) CARDIAC CATH PACK , Pack Number 00-401561K ;  6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;  7) LEFT HEART TRAY , Pack Number 00-401880I ;  8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;  9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;  10) ADVANTEC-MLD, Pack Number 00-500510D ;  11) ADVANTEC-MLD, Pack Number 00-500510F ;  12) KIT ANGIO CSTM-WALKER, Pack Number 129969;  13) DIAGNOSTIC KIT, Pack Number 147943;  14) MSC - CRESCENT MEDICAL, Pack Number 149155;  15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;  16) OPEN HEART CDS, Pack Number CDS840015AK;  17) OPEN HEART CDS, Pack Number CDS840015AL;  18) OPEN HEART CDS, Pack Number CDS840015AM;  19) OPEN HEART CDS, Pack Number CDS840015AN;  20) OPEN HEART CDS, Pack Number CDS840015AO;  21) OPEN HEART CDS, Pack Number CDS840015AP;  22) OPEN HEART CDS, Pack Number CDS840015AQ;  23) OPEN HEART CDS, Pack Number CDS840015AQ;  24) OPEN HEART CDS, Pack Number CDS840016AD;  25) OPEN HEART CDS, Pack Number CDS840016AD;  26) OPEN HEART CDS, Pack Number CDS840023R ;  27) OPEN HEART CDS, Pack Number CDS840023S ;  28) OPEN HEART CDS, Pack Number CDS840023T ;  29) AAA CDS , Pack Number CDS840076AC;  30) OFF PUMP CABG CDS , Pack Number CDS840087AB;  31) OFF PUMP CABG CDS , Pack Number CDS840087AD;  32) OFF PUMP CABG CDS , Pack Number CDS840087AF;  33) OFF PUMP CABG CDS , Pack Number CDS840087AG;  34) OFF PUMP CABG CDS , Pack Number CDS840087AI;  35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;  36) OFF PUMP CABG CDS , Pack Number CDS840087AK;  37) OFF PUMP CABG CDS , Pack Number CDS840087AL;  38) OPEN HEART CDS, Pack Number CDS840094L ;  39) OPEN HEART CDS, Pack Number CDS840094M ;  40) OPEN HEART CDS, Pack Number CDS840094N ;  41) OPEN HEART CDS, Pack Number CDS840094P ;  42) OPEN HEART CDS, Pack Number CDS840108J ;  43) OPEN HEART CDS, Pack Number CDS840108K ;  44) OPEN HEART CDS, Pack Number CDS840132N ;  45) OPEN HEART CDS, Pack Number CDS840132O ;  46) OPEN HEART CDS, Pack Number CDS840144O ;  47) OPEN HEART CDS, Pack Number CDS840144P ;  48) OPEN HEART CDS, Pack Number CDS840144Q ;  49) OPEN HEART CDS, Pack Number CDS840144Q ;  50) OPEN HEART CDS, Pack Number CDS840145S ;  51) OPEN HEART CDS, Pack Number CDS840145T ;  52) OPEN HEART CDS, Pack Number CDS840145U ;  53) OPEN HEART, Pack Number CDS840150R ;  54) OPEN HEART, Pack Number CDS840150S ;  55) OPEN HEART, Pack Number CDS840150T ;  56) OPEN HEART, Pack Number CDS840150U ;  57) OPEN HEART, Pack Number CDS840150V ;  58) PACEMAKER CDS , Pack Number CDS840162S ;  59) PACEMAKER CDS , Pack Number CDS840162T ;  60) PACEMAKER CDS , Pack Number CDS840162U ;  61) PACEMAKER CDS , Pack Number CDS840162V ;  62) OPEN HEART CDS, Pack Number CDS840171AA;  63) OPEN HEART CDS, Pack Number CDS840171AB;  64) OPEN HEART CDS, Pack Number CDS840171AC;  65) OPEN HEART CDS, Pack Number CDS840171AD;  66) HEART CDS , Pack Number CDS840179M ;  67) HEART CDS, Pack Number CDS840179M ;  68) MINOR VASCULAR PACK , Pack Number CDS840184M ;  69) MINOR VASCULAR PACK , Pack Number CDS840184N ;  70) MINOR VASCULAR PACK , Pack Number CDS840184O ;  71) MINOR VASCULAR PACK, Pack Number CDS840184P;  72) OPEN HEART PACK , Pack Number CDS840185S ;  73) OPEN HEART PACK , Pack Number CDS840185T ;  74) OPEN HEART PACK , Pack Number CDS840185U ;  75) OPEN HEART PACK , Pack Number CDS840185V ;  76) OPEN HEART PACK , Pack Number CDS840185W ;  77) VALVE PACK, Pack Number CDS840187S ;  78) VALVE PACK, Pack Number CDS840187T ;  79) OPEN HEART, Pack Number CDS840189R ;  80) MAJOR VASCULAR, Pack Number CDS840195T ;  81) MAJOR VASCULAR, Pack Number CDS840195U ;  82) CABG-LF , Pack Number CDS840231Q ;  83) CABG-LF , Pack Number CDS840231R ;  84) CABG-LF , Pack Number CDS840231S ;  85) CABG-LF , Pack Number CDS840231T ;  86) MAJOR VASCU",
      "text": "The FDA logged enforcement record Z-2995-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline convenience kits labeled as:   1) PERMANENT PACING, Pack Number 00-400361J ;  2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ;  3) PACEMAKER TRAY, Pack Number 00-401521F ;  4) FEMORAL PACK, Pack Number 00-401525G ;  5) CARDIAC CATH PACK , Pack Number 00-401561K ;  6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ;  7) LEFT HEART TRAY , Pack Number 00-401880I ;  8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ;  9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ;  10) ADVANTEC-MLD, Pack Number 00-500510D ;  11) ADVANTEC-MLD, Pack Number 00-500510F ;  12) KIT ANGIO CSTM-WALKER, Pack Number 129969;  13) DIAGNOSTIC KIT, Pack Number 147943;  14) MSC - CRESCENT MEDICAL, Pack Number 149155;  15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111;  16) OPEN HEART CDS, Pack Number CDS840015AK;  17) OPEN HEART CDS, Pack Number CDS840015AL;  18) OPEN HEART CDS, Pack Number CDS840015AM;  19) OPEN HEART CDS, Pack Number CDS840015AN;  20) OPEN HEART CDS, Pack Number CDS840015AO;  21) OPEN HEART CDS, Pack Number CDS840015AP;  22) OPEN HEART CDS, Pack Number CDS840015AQ;  23) OPEN HEART CDS, Pack Number CDS840015AQ;  24) OPEN HEART CDS, Pack Number CDS840016AD;  25) OPEN HEART CDS, Pack Number CDS840016AD;  26) OPEN HEART CDS, Pack Number CDS840023R ;  27) OPEN HEART CDS, Pack Number CDS840023S ;  28) OPEN HEART CDS, Pack Number CDS840023T ;  29) AAA CDS , Pack Number CDS840076AC;  30) OFF PUMP CABG CDS , Pack Number CDS840087AB;  31) OFF PUMP CABG CDS , Pack Number CDS840087AD;  32) OFF PUMP CABG CDS , Pack Number CDS840087AF;  33) OFF PUMP CABG CDS , Pack Number CDS840087AG;  34) OFF PUMP CABG CDS , Pack Number CDS840087AI;  35) OFF PUMP CABG CDS , Pack Number CDS840087AJ;  36) OFF PUMP CABG CDS , Pack Number CDS840087AK;  37) OFF PUMP CABG CDS , Pack Number CDS840087AL;  38) OPEN HEART CDS, Pack Number CDS840094L ;  39) OPEN HEART CDS, Pack Number CDS840094M ;  40) OPEN HEART CDS, Pack Number CDS840094N ;  41) OPEN HEART CDS, Pack Number CDS840094P ;  42) OPEN HEART CDS, Pack Number CDS840108J ;  43) OPEN HEART CDS, Pack Number CDS840108K ;  44) OPEN HEART CDS, Pack Number CDS840132N ;  45) OPEN HEART CDS, Pack Number CDS840132O ;  46) OPEN HEART CDS, Pack Number CDS840144O ;  47) OPEN HEART CDS, Pack Number CDS840144P ;  48) OPEN HEART CDS, Pack Number CDS840144Q ;  49) OPEN HEART CDS, Pack Number CDS840144Q ;  50) OPEN HEART CDS, Pack Number CDS840145S ;  51) OPEN HEART CDS, Pack Number CDS840145T ;  52) OPEN HEART CDS, Pack Number CDS840145U ;  53) OPEN HEART, Pack Number CDS840150R ;  54) OPEN HEART, Pack Number CDS840150S ;  55) OPEN HEART, Pack Number CDS840150T ;  56) OPEN HEART, Pack Number CDS840150U ;  57) OPEN HEART, Pack Number CDS840150V ;  58) PACEMAKER CDS , Pack Number CDS840162S ;  59) PACEMAKER CDS , Pack Number CDS840162T ;  60) PACEMAKER CDS , Pack Number CDS840162U ;  61) PACEMAKER CDS , Pack Number CDS840162V ;  62) OPEN HEART CDS, Pack Number CDS840171AA;  63) OPEN HEART CDS, Pack Number CDS840171AB;  64) OPEN HEART CDS, Pack Number CDS840171AC;  65) OPEN HEART CDS, Pack Number CDS840171AD;  66) HEART CDS , Pack Number CDS840179M ;  67) HEART CDS, Pack Number CDS840179M ;  68) MINOR VASCULAR PACK , Pack Number CDS840184M ;  69) MINOR VASCULAR PACK , Pack Number CDS840184N ;  70) MINOR VASCULAR PACK , Pack Number CDS840184O ;  71) MINOR VASCULAR PACK, Pack Number CDS840184P;  72) OPEN HEART PACK , Pack Number CDS840185S ;  73) OPEN HEART PACK , Pack Number CDS840185T ;  74) OPEN HEART PACK , Pack Number CDS840185U ;  75) OPEN HEART PACK , Pack Number CDS840185V ;  76) OPEN HEART PACK , Pack Number CDS840185W ;  77) VALVE PACK, Pack Number CDS840187S ;  78) VALVE PACK, Pack Number CDS840187T ;  79) OPEN HEART, Pack Number CDS840189R ;  80) MAJOR VASCULAR, Pack Number CDS840195T ;  81) MAJOR VASCULAR, Pack Number CDS840195U ;  82) CABG-LF , Pack Number CDS840231Q ;  83) CABG-LF , Pack Number CDS840231R ;  84) CABG-LF , Pack Number CDS840231S ;  85) CABG-LF , Pack Number CDS840231T ;  86) MAJOR VASCU — reason: XXX. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: 00-400361J , Lot Number 19GMA398 ;  00-400361J , Lot Number 19KMB977 ;  00-400361J , Lot Number 20AMB625 ;  00-400361J , Lot Number 20CMB790 ;  00-400361J , Lot Number 20EMB935 ;  00-400361J , Lot Number 20HMD638 ;  00-400361J , Lot Number 20JMF103 ;  00-400361J , Lot Number 20LMD909 ;  00-400361J , Lot Number 21HMA255 ;  00-400361J , Lot Number 21HMD608 ;  00-400361J , Lot Number 21JMG396 ;  00-400361J , Lot Number 21LMF121 ;  00-400361J , Lot Number 22AME293 ;  00-400361J , Lot Number 22BMF391 ;  00-400361J , Lot Number 22HMA827 ;  00-400361J , Lot Number 22LMA159 ;  00-400361J , Lot Number 23CMA918 ;  00-400361J , Lot Number 23EMG313 ;  00-400361J , Lot Number 23HME323 ;  00-400361J , Lot Number 19DKC989 ;  00-400361J , Lot Number 19EKD171 ;  00-401185Q , Lot Number 21BMC803 ;  00-401185Q , Lot Number 21CMB169 ;  00-401185Q , Lot Number 21FME996 ;  00-401185Q , Lot Number 21HMC811 ;  00-401185Q , Lot Number 21JMF649 ;  00-401185Q , Lot Number 22AMB298 ;  00-401185Q , Lot Number 22CMH907 ;  00-401185Q , Lot Number 22EMA951 ;  00-401185Q , Lot Number 22EME874 ;  00-401185Q , Lot Number 22FMF282 ;  00-401185Q , Lot Number 22FMF580 ;  00-401185Q , Lot Number 22HME725 ;  00-401185Q , Lot Number 22IMD217 ;  00-401185Q , Lot Number 22LMA438 ;  00-401185Q , Lot Number 23CMD526 ;  00-401185Q , Lot Number 23EMF518 ;  00-401185Q , Lot Number 23GMD389 ;  00-401185Q , Lot Number 23HMH421 ;  00-401185Q , Lot Number 23IMH814 ;  00-401521F , Lot Number 22CBE464 ;  00-401521F , Lot Number 19BBD936 ;  00-401521F , Lot Number 19EBL198 ;  00-401521F , Lot Number 19WBB570 ;  00-401521F , Lot Number 20EBD061 ;  00-401521F , Lot Number 20EBK193 ;  00-401521F , Lot Number 23JBT733 ;  00-401521F , Lot Number 20LBC052 ;  00-401521F , Lot Number 21ABI211 ;  00-401525G , Lot Number 21GBO675 ;  00-401525G , Lot Number 21IBA321 ;  00-401525G , Lot Number 21JBW514 ;  00-401525G , Lot Number 21LBP821 ;  00-401525G , Lot Number 22BBW574 ;  00-401525G , Lot Number 22CBZ322 ;  00-401525G , Lot Number 22OBD345 ;  00-401525G , Lot Number 19DBA953 ;  00-401525G , Lot Number 22EBS321 ;  00-401525G , Lot Number 19EBX278 ;  00-401525G , Lot Number 19EBX645 ;  00-401525G , Lot Number 19GBK251 ;  00-401525G , Lot Number 19SBD727 ;  00-401525G , Lot Number 22JBF078 ;  00-401525G , Lot Number 22KBQ242 ;  00-401525G , Lot Number 19VBD535 ;  00-401525G , Lot Number 19KBP818 ;  00-401525G , Lot Number 19LBD342 ;  00-401525G , Lot Number 23CBL714 ;  00-401525G , Lot Number 23EBI077 ;  00-401525G , Lot Number 23FBH811 ;  00-401525G , Lot Number 20DBC252 ;  00-401525G , Lot Number 23GBW352 ;  00-401525G , Lot Number 23IBB620 ;  00-401525G , Lot Number 20EBS479 ;  00-401525G , Lot Number 23JBH811 ;  00-401525G , Lot Number 20GBT714 ;  00-401525G , Lot Number 20JBC305 ;  00-401525G , Lot Number 21ABE171 ;  00-401525G , Lot Number 21CBS174 ;  00-401525G , Lot Number 21EBR135 ;  00-401561K , Lot Number 19ABB458 ;  00-401561K , Lot Number 19ABY023 ;  00-401561K , Lot Number 19CBB584 ;  00-401561K , Lot Number 19DBG969 ;  00-401561K , Lot Number 19EBG778 ;  00-401561K , Lot Number 19FBM963 ;  00-401561K , Lot Number 19SBG949 ;  00-401561K , Lot Number 19KBE358 ;  00-401594S , Lot Number 21EDA345 ;  00-401594S , Lot Number 21GDC290 ;  00-401594S , Lot Number 21HDC372 ;  00-401594S , Lot Number 21KDB536 ;  00-401594S , Lot Number 22BDA106 ;  00-401594S , Lot Number 22CDB669 ;  00-401594S , Lot Number 22CDC224 ;  00-401594S , Lot Number 22FDA001 ;  00-401594S , Lot Number 22GDA339 ;  00-401594S , Lot Number 22IDA127 ;  00-401594S , Lot Number 22JDC194 ;  00-401594S , Lot Number 23BDA244 ;  00-401594S , Lot Number 23BDB723 ;  00-401594S , Lot Number 23DDA900 ;  00-401594S , Lot Number 23FDB364 ;  00-401594S , Lot Number 23GDB492 ;  00-401594S , Lot Number 23JDA045 ;  00-401594S , Lot Number 23LDC052 ;  00-401594S , Lot Number 24BDA515 ;  00-401880I , Lot Number 21FBR920 ;  00-401880I , Lot Number 21IBN364 ;  00-401880I , Lot Number 21KBJ427 ;  00-401880I , Lot Number 22ABH895 ;  00-401880I , Lot Number 22BBU351 ;  00-401880I , Lot Number 19ABO520 ;  00-401880I , Lot Number 19DBQ061 ;  00-401880I , Lot Number 22FBO924 ;  00-401880I , Lot Number 19FBM977 ;  00-401880I , Lot Number 19SBF703 ;  00-401880I , Lot Number 22JBC747 ;  00-401880I , Lot Number 22LBO277 ;  00-401880I , Lot Number 22LBO735 ;  00-401880I , Lot Number 22LBP364 ;  00-401880I , Lot Number 19JBV415 ;  00-401880I , Lot Number 20BBE782 ;  00-401880I , Lot Number 20FBH730 ;  00-401880I , Lot Number 23JBI807 ;  00-401880I , Lot Number 23KBP558 ;  00-401880I , Lot Number 20HBW267 ;  00-401880I , Lot Number 21ABE437 ;  00-401880I , Lot Number 21CBB803 ;  00-401880I , Lot Number 21EBB401 ;  00-401893K , Lot Number 19BDA313 ;  00-401893K , Lot Number 19DDC831 ;  00-401893K , Lot Number 19GDA588 ;  00-401893K , Lot Number 19GDC053 ;  00-401893K , Lot Number 19IDA009 ;  00-401893K , Lot Number 19JMB407 ;  00-401893K , Lot Number 19LMA556 ;  00-401893K , Lot Number 20AMC670 ;  00-401893K , Lot Number 20CMA801 ;  00-401893K , Lot Number 20EMA701 ;  00-401893K , Lot Number 20HMD901 ;  00-401893K , Lot Number 21AMA759 ;  00-401893K , Lot Number 21AMC286 ;  00-401893K , Lot Number 21CMB164 ;  00-401893K , Lot Number 21GMD267 ;  00-401893K , Lot Number 21HMF130 ;  00-401893K , Lot Number 21JMB601 ;  00-401893K , Lot Number 21LMF357 ;  00-401893L , Lot Number 23FBM719 ;  00-401893L , Lot Number 23HBR879 ;  00-401893L , Lot Number 23JBX744 ;  00-401893L , Lot Number 24ABQ827 ;  00-401893L , Lot Number 22CMD657 ;  00-401893L , Lot Number 22DMJ075 ;  00-401893L , Lot Number 22IMG828 ;  00-401893L , Lot Number 22JMC769 ;  00-401893L , Lot Number 22KMG913 ;  00-401893L , Lot Number 23AMI218 ;  00-401893L , Lot Number 23CMD959 ;  00-401893L , Lot Number 23EMD512 ;  00-500510D , Lot Number 21FBI165 ;  00-500510D , Lot Number 21FBI418 ;  00-500510D , Lot Number 21GBH514 ;  00-500510D , Lot Number 21GBT047 ;  00-500510D , Lot Number 21HBI423 ;  00-500510D , Lot Number 21IBN225 ;  00-500510D , Lot Number 21VBB295 ;  00-500510D , Lot Number 21KBF665 ;  00-500510D , Lot Number 21KBP859 ;  00-500510D , Lot Number 21LBK037 ;  00-500510D , Lot Number 21LBV855 ;  00-500510D , Lot Number 19ABF836 ;  00-500510D , Lot Number 22BBT369 ;  00-500510D , Lot Number 22BBT370 ;  00-500510D , Lot Number 22BBT373 ;  00-500510D , Lot Number 22NBD250 ;  00-500510D , Lot Number 19ABY556 ;  00-500510D , Lot Number 22CBS531 ;  00-500510D , Lot Number 19CBF033 ;  00-500510D , Lot Number 22OBE487 ;  00-500510D , Lot Number 19CBQ541 ;  00-500510D , Lot Number 19DBC193 ;  00-500510D , Lot Number 19DBV833 ;  00-500510D , Lot Number 19EBO551 ;  00-500510D , Lot Number 22FBR999 ;  00-500510D , Lot Number 19EBZ886 ;  00-500510D , Lot Number 19FBI015 ;  00-500510D , Lot Number 19FBI471 ;  00-500510D , Lot Number 19GBI858 ;  00-500510D , Lot Number 19HBH384 ;  00-500510D , Lot Number 19IBE371 ;  00-500510D , Lot Number 19IBF032 ;  00-500510D , Lot Number 19IBI219 ;  00-500510D , Lot Number 19JBL103 ;  00-500510D , Lot Number 19VBA392 ;  00-500510D , Lot Number 19VBB518 ;  00-500510D , Lot Number 19KBQ007 ;  00-500510D , Lot Number 19KBU914 ;  00-500510D , Lot Number 19LBC188 ;  00-500510D , Lot Number 19LBL331 ;  00-500510D , Lot Number 20ABQ871 ;  00-500510D , Lot Number 20BBU110 ;  00-500510D , Lot Number 20BBY738 ;  00-500510D , Lot Number 20CBL120 ;  00-500510D , Lot Number 20DBA938 ;  00-500510D , Lot Number 20EBN261 ;  00-500510D , Lot Number 20EBQ580 ;  00-500510D , Lot Number 20GBO712 ;  00-500510D , Lot Number 20GBR966 ;  00-500510D , Lot Number 21ABQ685 ;  00-500510D , Lot Number 21BBD205 ;  00-500510D , Lot Number 21DBQ654 ;  00-500510F , Lot Number 22HBU530 ;  00-500510F , Lot Number 22KBB372 ;  00-500510F , Lot Number 23ABD122 ;  00-500510F , Lot Number 23ABE574 ;  00-500510F , Lot Number 23CBG780 ;  00-500510F , Lot Number 23CBJ408 ;  00-500510F , Lot Number 23EBC431 ;  00-500510F , Lot Number 23EBU664 ;  00-500510F , Lot Number 23FBC616 ;  00-500510F , Lot Number 23GBE309 ;  00-500510F , Lot Number 23GBS398 ;  00-500510F , Lot Number 23JBN173 ;  00-500510F , Lot Number 23LBE584 ;  129969, Lot Number 22BBK642;  129969, Lot Number 22IBB549;  147943, Lot Number 24ABU386;  147943, Lot Number 24ABB395;  147943, Lot Number 23LBH739;  147943, Lot Number 23KBW964;  147943, Lot Number 23IBR202;  147943, Lot Number 23IBJ020;  147943, Lot Number 23HBT017;  147943, Lot Number 23HBF624;  147943, Lot Number 23FBN683;  149155, Lot Number 23JBH149;  650123111, Lot Number 21KBZ481 ;  650123111, Lot Number 22OBH018 ;  650123111, Lot Number 22HBF027 ;  650123111, Lot Number 22HBM362 ;  650123111, Lot Number 22IBD609 ;  650123111, Lot Number 22LBJ613 ;  650123111, Lot Number 23EBB875 ;  650123111, Lot Number 23FBM247 ;  650123111, Lot Number 23HBE368 ;  650123111, Lot Number 23KBJ892 ;  CDS840015AK, Lot Number 19ABN979 ;  CDS840015AK, Lot Number 19BBM872 ;  CDS840015AK, Lot Number 19CBC958 ;  CDS840015AK, Lot Number 19DBG300 ;  CDS840015AL, Lot Number 19FBM446 ;  CDS840015AL, Lot Number 19GBR813 ;  CDS840015AL, Lot Number 19SBH381 ;  CDS840015AL, Lot Number 19HBP412 ;  CDS840015AM, Lot Number 19KLA416 ;  CDS840015AM, Lot Number 19KLA589 ;  CDS840015AM, Lot Number 19LLA500 ;  CDS840015AM, Lot Number 20ALA122 ;  CDS840015AM, Lot Number 20ALA701 ;  CDS840015AN, Lot Number 20BLA588 ;  CDS840015AN, Lot Number 20ELA580 ;  CDS840015AN, Lot Number 20JLA162 ;  CDS840015AN, Lot Number 20JLA716 ;  CDS840015AN, Lot Number 20KLA001 ;  CDS840015AN, Lot Number 20KLA152 ;  CDS840015AO, Lot Number 21ALA434 ;  CDS840015AO, Lot Number 21ALA450 ;  CDS840015AO, Lot Number 21BLA535 ;  CDS840015AO, Lot Number 21CLA241 ;  CDS840015AO, Lot Number 21FLA629 ;  CDS840015AO, Lot Number 21GLA233 ;  CDS840015AO, Lot Number 21GLA426 ;  CDS840015AO, Lot Number 21HLA058 ;  CDS840015AP, Lot Number 21KLA366 ;  CDS840015AP, Lot Number 22ALA405 ;  CDS840015AP, Lot Number 22BLA377 ;  CDS840015AP, Lot Number 22BLB099 ;  CDS840015AP, Lot Number 22DLA779 ;  CDS840015AP, Lot Number 22ELA330 ;  CDS840015AP, Lot Number 22GLA236 ;  CDS840015AP, Lot Number 22GLA758 ;  CDS840015AP, Lot Number 22GLB010 ;  CDS840015AP, Lot Number 22HLA483 ;  CDS840015AQ, Lot Number 22LLA456 ;  CDS840015AQ, Lot Number 22LLA822 ;  CDS840015AQ, Lot Number 23BLA228 ;  CDS840015AQ, Lot Number 23BLA824 ;  CDS840015AQ, Lot Number 23DLA416 ;  CDS840015AQ, Lot Number 23DLA677 ;  CDS840015AQ, Lot Number 23DLB107 ;  CDS840015AQ, Lot Number 23ELA682 ;  CDS840015AQ, Lot Number 23FLA191 ;  CDS840015AQ, Lot Number 23FLA519 ;  CDS840015AQ, Lot Number 23GLB212 ;  CDS840015AQ, Lot Number 23HLA522 ;  CDS840015AQ, Lot Number 23ILA042 ;  CDS840015AQ, Lot Number 23JLB173 ;  CDS840015AQ, Lot Number 23LLA688 ;  CDS840015AQ, Lot Number 24BLA549 ;  CDS840015AQ, Lot Number 24CLA640 ;  CDS840016AD, Lot Number 21GBE959 ;  CDS840016AD, Lot Number 21HBJ898 ;  CDS840016AD, Lot Number 21LBH187 ;  CDS840016AD, Lot Number 22ABY331 ;  CDS840016AD, Lot Number 22DBQ101 ;  CDS840016AD, Lot Number 22EBC449 ;  CDS840016AD, Lot Number 22FBH312 ;  CDS840016AD, Lot Number 22HBM674 ;  CDS840016AD, Lot Number 22HBM675 ;  CDS840016AD, Lot Number 22IBC587 ;  CDS840016AD, Lot Number 19HBO685 ;  CDS840016AD, Lot Number 22KBB889 ;  CDS840016AD, Lot Number 19JBR664 ;  CDS840016AD, Lot Number 19JBW644 ;  CDS840016AD, Lot Number 23ABK208 ;  CDS840016AD, Lot Number 23CBU665 ;  CDS840016AD, Lot Number 23CBV808 ;  CDS840016AD, Lot Number 19LBW504 ;  CDS840016AD, Lot Number 23EBD314 ;  CDS840016AD, Lot Number 23EBG200 ;  CDS840016AD, Lot Number 23EBX041 ;  CDS840016AD, Lot Number 23FBR732 ;  CDS840016AD, Lot Number 20CBN891 ;  CDS840016AD, Lot Number 20CBN924 ;  CDS840016AD, Lot Number 23HBA346 ;  CDS840016AD, Lot Number 23HBY326 ;  CDS840016AD, Lot Number 20EBO288 ;  CDS840016AD, Lot Number 20EBS065 ;  CDS840016AD, Lot Number 23IBO533 ;  CDS840016AD, Lot Number 20EBW131 ;  CDS840016AD, Lot Number 23JBK436 ;  CDS840016AD, Lot Number 20GBA406 ;  CDS840016AD, Lot Number 23JBT305 ;  CDS840016AD, Lot Number 23JBY115 ;  CDS840016AD, Lot Number 23KBJ607 ;  CDS840016AD, Lot Number 20HBP261 ;  CDS840016AD, Lot Number 20HBQ828 ;  CDS840016AD, Lot Number 24ABG468 ; 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 CDS840184P , Lot Number 23KME149 ;  CDS840185S , Lot Number 19AKB086 ;  CDS840185S , Lot Number 19BKB841 ;  CDS840185T , Lot Number 19DKA271 ;  CDS840185T , Lot Number 19EKD810 ;  CDS840185T , Lot Number 19HKB424 ;  CDS840185T , Lot Number 19KKA620 ;  CDS840185T , Lot Number 20AKA921 ;  CDS840185T , Lot Number 20BKA408 ;  CDS840185T , Lot Number 20BKA543 ;  CDS840185T , Lot Number 20BKB164 ;  CDS840185T , Lot Number 20CKA792 ;  CDS840185T , Lot Number 20HKB818 ;  CDS840185T , Lot Number 21CKA251 ;  CDS840185U , Lot Number 21FMB007 ;  CDS840185U , Lot Number 21FMB299 ;  CDS840185U , Lot Number 21GMB134 ;  CDS840185U , Lot Number 21GMC837 ;  CDS840185U , Lot Number 21IMA908 ;  CDS840185U , Lot Number 21KMA527 ;  CDS840185V , Lot Number 22KMF107 ;  CDS840185V , Lot Number 22LMG454 ;  CDS840185V , Lot Number 23EMF369 ;  CDS840185V , Lot Number 23KMI614 ;  CDS840185W , Lot Number 24AMH833 ;  CDS840185W , Lot Number 24BMB058 ;  CDS840187S , Lot Number 19GKC791 ;  CDS840187S , Lot Number 19JKB694 ;  CDS840187S , Lot Number 19KKA197 ;  CDS840187S , Lot Number 19LKA620 ;  CDS840187S , Lot Number 20BKA557 ;  CDS840187S , Lot Number 20DKA870 ;  CDS840187S , Lot Number 20GKB141 ;  CDS840187T , Lot Number 21FMB236 ;  CDS840187T , Lot Number 21FME640 ;  CDS840187T , Lot Number 21HMD893 ;  CDS840187T , Lot Number 22AMF457 ;  CDS840187T , Lot Number 22CMC917 ;  CDS840187T , Lot Number 22FMG280 ;  CDS840187T , Lot Number 22HMA002 ;  CDS840187T , Lot Number 22IMD574 ;  CDS840187T , Lot Number 22IMF709 ;  CDS840187T , Lot Number 22JMG653 ;  CDS840187T , Lot Number 22KMG318 ;  CDS840187T , Lot Number 23DMH020 ;  CDS840187T , Lot Number 23EMD178 ;  CDS840187T , Lot Number 23FMD535 ;  CDS840187T , Lot Number 23LMD524 ;  CDS840187T , Lot Number 23LMH824 ;  CDS840187T , Lot Number 24AMJ390 ;  CDS840187T , Lot Number 21DKA491 ;  CDS840189R , Lot Number 19BKA386 ;  CDS840189R , Lot Number 19BKC818 ;  CDS840189R , Lot Number 19CKB869 ;  CDS840189R , Lot Number 19CKD146 ;  CDS840195T , Lot Number 21FMB552 ; 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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-2995-2024&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-2995-2024&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-2995-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2995-2024 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",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "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-2995-2024&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-2995-2024&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-2995-2024/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",
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      "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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 CDS840171AA, Lot Number 22ABW436 ;  CDS840171AA, Lot Number 22BBQ794 ;  CDS840171AA, Lot Number 22CMF202 ;  CDS840171AA, Lot Number 22CMF807 ;  CDS840171AA, Lot Number 22DMI794 ;  CDS840171AB, Lot Number 22EMG542 ;  CDS840171AB, Lot Number 22GMG011 ;  CDS840171AB, Lot Number 22HMG560 ;  CDS840171AC, Lot Number 22GMH076 ;  CDS840171AC, Lot Number 22HMG266 ;  CDS840171AC, Lot Number 22IMC485 ;  CDS840171AC, Lot Number 22KMB419 ;  CDS840171AC, Lot Number 22LMD442 ;  CDS840171AC, Lot Number 23CMG687 ;  CDS840171AD, Lot Number 23GMB956 ;  CDS840171AD, Lot Number 23JMD203 ;  CDS840171AD, Lot Number 23JME395 ;  CDS840171AD, Lot Number 23JMF944 ;  CDS840171AD, Lot Number 23KME173 ;  CDS840179M , Lot Number 21GBU902 ;  CDS840179M , Lot Number 21IBS492 ;  CDS840179M , Lot Number 21IBV684 ;  CDS840179M , Lot Number 22CBM613 ;  CDS840179M , Lot Number 19BBQ377 ;  CDS840179M , Lot Number 22CBU924 ;  CDS840179M , Lot Number 19CBN962 ;  CDS840179M , Lot Number 19DBS190 ;  CDS840179M , Lot Number 22FBH408 ;  CDS840179M , Lot Number 19EBW409 ;  CDS840179M , Lot Number 19GBQ735 ;  CDS840179M , Lot Number 22IBQ944 ;  CDS840179M , Lot Number 22JBJ710 ;  CDS840179M , Lot Number 19IBW710 ;  CDS840179M , Lot Number 22KBT096 ;  CDS840179M , Lot Number 22KBT202 ;  CDS840179M , Lot Number 22KBT203 ;  CDS840179M , Lot Number 23BBD729 ;  CDS840179M , Lot Number 23DBT133 ;  CDS840179M , Lot Number 23EBA474 ;  CDS840179M , Lot Number 20BBW208 ;  CDS840179M , Lot Number 23GBT785 ;  CDS840179M , Lot Number 20DBM184 ;  CDS840179M , Lot Number 23HBP976 ;  CDS840179M , Lot Number 20EBV028 ;  CDS840179M , Lot Number 23IBT068 ;  CDS840179M , Lot Number 20HBC015 ;  CDS840179M , Lot Number 23LBC741 ;  CDS840179M , Lot Number 20IBQ927 ;  CDS840179M , Lot Number 21ABW996 ;  CDS840179M , Lot Number 21ABX529 ;  CDS840179M , Lot Number 21DBA309 ;  CDS840179M , Lot Number 21DBG113 ;  CDS840179M , Lot Number 21EBO593 ;  CDS840179M , Lot Number 24BBE226 ;  CDS840184M , Lot Number 19CKD248 ;  CDS840184N , Lot Number 19FKC134 ;  CDS840184N , Lot Number 19GKB143 ;  CDS840184N , Lot Number 19GKC784 ;  CDS840184N , Lot Number 19HKA938 ;  CDS840184N , Lot Number 19IKB128 ;  CDS840184N , Lot Number 19JKC137 ;  CDS840184N , Lot Number 20AKB908 ;  CDS840184N , Lot Number 20CKA621 ;  CDS840184N , Lot Number 20FKA899 ;  CDS840184N , Lot Number 20GKA245 ;  CDS840184N , Lot Number 20GKB061 ;  CDS840184N , Lot Number 20HKA078 ;  CDS840184N , Lot Number 20JKA815 ;  CDS840184N , Lot Number 21AKB031 ;  CDS840184O , Lot Number 21DME472 ;  CDS840184O , Lot Number 21IMF705 ;  CDS840184O , Lot Number 21JMI051 ;  CDS840184O , Lot Number 21LMC275 ;  CDS840184O , Lot Number 22CMH045 ;  CDS840184O , Lot Number 22CMH045Z;  CDS840184O , Lot Number 22FMC203 ;  CDS840184O , Lot Number 22JMF329 ;  CDS840184O , Lot Number 22JMG514 ;  CDS840184O , Lot Number 23AME147 ;  CDS840184O , Lot Number 23GMA425 ;  CDS840184O , Lot Number 23HMB804 ;  CDS840184O , Lot Number 21CKA224 ;  CDS840184P, Lot Number 24CMG991;  CDS840184P, Lot Number 24CMG438;  CDS840184P , Lot Number 23KME149 ;  CDS840185S , Lot Number 19AKB086 ;  CDS840185S , Lot Number 19BKB841 ;  CDS840185T , Lot Number 19DKA271 ;  CDS840185T , Lot Number 19EKD810 ;  CDS840185T , Lot Number 19HKB424 ;  CDS840185T , Lot Number 19KKA620 ;  CDS840185T , Lot Number 20AKA921 ;  CDS840185T , Lot Number 20BKA408 ;  CDS840185T , Lot Number 20BKA543 ;  CDS840185T , Lot Number 20BKB164 ;  CDS840185T , Lot Number 20CKA792 ;  CDS840185T , Lot Number 20HKB818 ;  CDS840185T , Lot Number 21CKA251 ;  CDS840185U , Lot Number 21FMB007 ;  CDS840185U , Lot Number 21FMB299 ;  CDS840185U , Lot Number 21GMB134 ;  CDS840185U , Lot Number 21GMC837 ;  CDS840185U , Lot Number 21IMA908 ;  CDS840185U , Lot Number 21KMA527 ;  CDS840185V , Lot Number 22KMF107 ;  CDS840185V , Lot Number 22LMG454 ;  CDS840185V , Lot Number 23EMF369 ;  CDS840185V , Lot Number 23KMI614 ;  CDS840185W , Lot Number 24AMH833 ;  CDS840185W , Lot Number 24BMB058 ;  CDS840187S , Lot Number 19GKC791 ;  CDS840187S , Lot Number 19JKB694 ;  CDS840187S , Lot Number 19KKA197 ;  CDS840187S , Lot Number 19LKA620 ;  CDS840187S , Lot Number 20BKA557 ;  CDS840187S , Lot Number 20DKA870 ;  CDS840187S , Lot Number 20GKB141 ;  CDS840187T , Lot Number 21FMB236 ;  CDS840187T , Lot Number 21FME640 ;  CDS840187T , Lot Number 21HMD893 ;  CDS840187T , Lot Number 22AMF457 ;  CDS840187T , Lot Number 22CMC917 ;  CDS840187T , Lot Number 22FMG280 ;  CDS840187T , Lot Number 22HMA002 ;  CDS840187T , Lot Number 22IMD574 ;  CDS840187T , Lot Number 22IMF709 ;  CDS840187T , Lot Number 22JMG653 ;  CDS840187T , Lot Number 22KMG318 ;  CDS840187T , Lot Number 23DMH020 ;  CDS840187T , Lot Number 23EMD178 ;  CDS840187T , Lot Number 23FMD535 ;  CDS840187T , Lot Number 23LMD524 ;  CDS840187T , Lot Number 23LMH824 ;  CDS840187T , Lot Number 24AMJ390 ;  CDS840187T , Lot Number 21DKA491 ;  CDS840189R , Lot Number 19BKA386 ;  CDS840189R , Lot Number 19BKC818 ;  CDS840189R , Lot Number 19CKB869 ;  CDS840189R , Lot Number 19CKD146 ;  CDS840195T , Lot Number 21FMB552 ;  CDS840195T , Lot Number 21HMC403 ;  CDS840195T , Lot Number 20EKA717 ;  CDS840195T , Lot Number 21AKA081 ;  CDS840195T , Lot Number 21BKA579 ;  CDS840195T , Lot Number 21CKA227 ;  CDS840195U , Lot Number 21JMB645 ;  CDS840195U , Lot Number 21JME382 ;  CDS840195U , Lot Number 21JMG165 ;  CDS840195U , Lot Number 22DMG973 ;  CDS840195U , Lot Number 23DMC061 ;  CDS840195U , Lot Number 23EMD595 ;  CDS840195U , Lot Number 23FMI496 ;  CDS840195U , Lot Number 23HMD269 ;  CDS840231Q , Lot Number 19ABW865 ;  CDS840231Q , Lot Number 19CBM653 ;  CDS840231Q , Lot Number 19PBB944 ;  CDS840231Q , Lot Number 19QBA585 ;  CDS840231Q , Lot Number 19GBJ910 ;  CDS840231Q , Lot Number 19TBB330 ;  CDS840231Q , Lot Number 19IBK311 ;  CDS840231Q , Lot Number 19JBK940 ;  CDS840231Q , Lot Number 19KBA016 ;  CDS840231Q , Lot Number 20ABQ213 ;  CDS840231Q , Lot Number 20BBJ966 ;  CDS840231Q , Lot Number 20DBO098 ;  CDS840231R , Lot Number 21GBW332 ;  CDS840231R , Lot Number 21IBX701 ;  CDS840231R , Lot Number 20EBS055 ;  CDS840231R , Lot Number 20FBC956 ;  CDS840231R , Lot Number 20GBJ875 ;  CDS840231R , Lot Number 20IBR124 ;  CDS840231R , Lot Number 20JBX637 ;  CDS840231R , Lot Number 20KBS117 ;  CDS840231R , Lot Number 21BBG045 ;  CDS840231R , Lot Number 21CBG468 ;  CDS840231R , Lot Number 21CBH403 ;  CDS840231R , Lot Number 21CBR549 ;  CDS840231R , Lot Number 21EBQ804 ;  CDS840231R , Lot Number 21FBD643 ;  CDS840231S , Lot Number 22ABS894 ;  CDS840231S , Lot Number 22BBZ826 ;  CDS840231S , Lot Number 22CBU922 ;  CDS840231S , Lot Number 22EBI057 ;  CDS840231S , Lot Number 22FBT378 ;  CDS840231S , Lot Number 22IBT603 ;  CDS840231S , Lot Number 22IBT892 ;  CDS840231S , Lot Number 22LBB567 ;  CDS840231S , Lot Number 22LBB568 ;  CDS840231S , Lot Number 23ABQ332 ;  CDS840231S , Lot Number 23CBP687 ;  CDS840231S , Lot Number 23DBD693 ;  CDS840231S , Lot Number 23EBG911 ;  CDS840231S , Lot Number 23GBL901 ;  CDS840231S , Lot Number 23GBN733 ;  CDS840231S , Lot Number 23IBS026 ;  CDS840231T , Lot Number 23LLA441 ;  CDS840231T , Lot Number 24ALA060 ;  CDS840231T , Lot Number 24ALA384 ;  CDS840231T , Lot Number 24ALA796 ;  CDS840231T , Lot Number 24CLA509 ;  CDS840232K , Lot Number 21GBB798 ;  CDS840232K , Lot Number 21GBQ453 ;  CDS840232K , Lot Number 21HBO922 ;  CDS840232K , Lot Number 20EBI686 ;  CDS840232K , Lot Number 20GBH153 ;  CDS840232K , Lot Number 20HBH802 ;  CDS840232K , Lot Number 20IBS980 ;  CDS840232K , Lot Number 20JBU645 ;  CDS840232K , Lot Number 20JBX085 ;  CDS840232K , Lot Number 20KBJ537 ;  CDS840232K , Lot Number 20KBU777 ;  CDS840232K , Lot Number 20LBF164 ;  CDS840232K , Lot Number 21CBH405 ;  CDS840232K , Lot Number 21DBP538 ;  CDS840232L , Lot Number 21LBT071 ;  CDS840232L , Lot Number 22ABD374 ;  CDS840232L , Lot Number 22OBA532 ;  CDS840232L , Lot Number 22OBM343 ;  CDS840232L , Lot Number 22FBF374 ;  CDS840232L , Lot Number 22FBX255 ;  CDS840232L , Lot Number 22HBV242 ;  CDS840232L , Lot Number 22IBA190 ;  CDS840232L , Lot Number 22JBL420 ;  CDS840232L , Lot Number 22LBQ596 ;  CDS840232L , Lot Number 23ABQ980 ;  CDS840232L , Lot Number 23CBW366 ;  CDS840232L , Lot Number 23CBW387 ;  CDS840232L , Lot Number 23EBQ492 ;  CDS840232L , Lot Number 23IBS976 ;  CDS840232M , Lot Number 23LBJ602 ;  CDS840232M , Lot Number 24ABP181 ;  CDS840233I , Lot Number 22ABN888 ;  CDS840233I , Lot Number 22ABT326 ;  CDS84023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}