{
  "@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-3042-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;  2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;  3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ;  4) NEURO CDS , Pack Number CDS780056K ;  5) NEURO CDS , Pack Number CDS780056L ;  6) SHUNT CDS-LF, Pack Number CDS780103K ;  7) NEURO CDS , Pack Number CDS780108T ;  8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ;  9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ;  10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ;  11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ;  12) NEURO CDS , Pack Number CDS780162AA;  13) NEURO CDS , Pack Number CDS780162AB;  14) NEURO CDS , Pack Number CDS780162AC;  15) NEURO CDS , Pack Number CDS780162AD;  16) NEURO CDS , Pack Number CDS780162X ;  17) NEURO CDS , Pack Number CDS780162Y ;  18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ;  19) BASIC NEURO PACK, Pack Number CDS780202L ;  20) BASIC NEURO PACK, Pack Number CDS780202O ;  21) BASIC NEURO PACK, Pack Number CDS780202P ;  22) BASIC NEURO PACK, Pack Number CDS780202Q ;  23) BASIC NEURO PACK, Pack Number CDS780202R ;  24) NEURO-LAMI CDS, Pack Number CDS780208D ;  25) NEURO-LAMI CDS, Pack Number CDS780208F ;  26) NEURO CDS, Pack Number CDS780230K;  27) NEURO CDS , Pack Number CDS780230K ;  28) VP SHUNT, Pack Number CDS840193U ;  29) NEURO CDS-LF, Pack Number CDS980853N ;  30) VP SHUNT CDS-LF , Pack Number CDS981084K ;  31) VP SHUNT CDS-LF , Pack Number CDS981084L ;  32) VP SHUNT CDS-LF , Pack Number CDS981084M ;  33) NEURO KIT , Pack Number CDS981327N ;  34) NEURO KIT , Pack Number CDS981327O ;  35) NEURO KIT , Pack Number CDS981327P ;  36) NERVE STIMULATOR, Pack Number CDS981579N ;  37) NEURO MINOR CDS , Pack Number CDS981708K ;  38) VP SHUNT CDS, Pack Number CDS981740F ;  39) VP SHUNT CDS, Pack Number CDS981740J ;  40) VP SHUNT CDS, Pack Number CDS981740K ;  41) VP SHUNT CDS, Pack Number CDS981740KH;  42) MICRO DISC CDS, Pack Number CDS981886P ;  43) MICRO DISC CDS, Pack Number CDS981886R ;  44) MICRO DISC CDS, Pack Number CDS981886S ;  45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ;  46) NEURO CDS , Pack Number CDS982603L ;  47) NEURO CDS , Pack Number CDS982603M ;  48) NEURO CDS , Pack Number CDS982603N ;  49) NEURO SPINE CDS , Pack Number CDS982683Q ;  50) MAJOR NEURO , Pack Number CDS982704K ;  51) MAJOR NEURO , Pack Number CDS982704M ;  52) MAJOR NEURO , Pack Number CDS982704N ;  53) NEURO CDS CHS-LF, Pack Number CDS982745D ;  54) NEURO CDS CHS-LF, Pack Number CDS982745F ;  55) NEURO CDS CHS-LF, Pack Number CDS982745G ;  56) AV SHUNT CDS, Pack Number CDS983098D ;  57) AV SHUNT CDS, Pack Number CDS983098F ;  58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ;  59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ;  60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ;  61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ;  62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ;  63) VP SHUNT, Pack Number CDS983366J ;  64) VP SHUNT, Pack Number CDS983366M ;  65) VP SHUNT, Pack Number CDS983366N ;  66) VP SHUNT, Pack Number CDS983366P ;  67) NEURO CDS-LF, Pack Number CDS983383F ;  68) NEURO CDS-LF, Pack Number CDS983383G ;  69) NEURO CDS-LF, Pack Number CDS983383I ;  70) NEURO CDS-LF, Pack Number CDS983383J ;  71) AV SHUNT CDS, Pack Number CDS983792C ;  72) AV SHUNT CDS, Pack Number CDS983792D ;  73) ANTERIOR NEURO CDS, Pack Number CDS983882C ;  74) ANTERIOR NEURO CDS, Pack Number CDS983882D ;  75) POSTERIOR NEURO CDS , Pack Number CDS983885C ;  76) POSTERIOR NEURO CDS , Pack Number CDS983885D ;  77) POSTERIOR NEURO CDS , Pack Number CDS983885F ;  78) NEURO CDS , Pack Number CDS983981D ;  79) NEURO CDS , Pack Number CDS983981F ;  80) NEURO CDS , Pack Number CDS983981I ;  81) NEURO CDS , Pack Number CDS983981J ;  82) NEURO CDS , Pack Number CDS983981K ;  83) NEURO CDS , Pack Number CDS983981L ;  84) CRANI NEURO CDS , Pack Number CDS984172F ;  85) PUH NEURO EEA CDS , Pack Number CDS984297G ;  86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ;  87) ME",
  "description": "FDA recall Z-3042-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;  2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;  3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ;  4) NEURO CDS , Pack Number CDS780056K ;  5) NEURO CDS , Pack Number CDS780056L ;  6) SHUNT CDS-LF, Pack Number CDS780103K ;  7) NEURO CDS , Pack Number CDS780108T ;  8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ;  9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ;  10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ;  11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ;  12) NEURO CDS , Pack Number CDS780162AA;  13) NEURO CDS , Pack Number CDS780162AB;  14) NEURO CDS , Pack Number CDS780162AC;  15) NEURO CDS , Pack Number CDS780162AD;  16) NEURO CDS , Pack Number CDS780162X ;  17) NEURO CDS , Pack Number CDS780162Y ;  18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ;  19) BASIC NEURO PACK, Pack Number CDS780202L ;  20) BASIC NEURO PACK, Pack Number CDS780202O ;  21) BASIC NEURO PACK, Pack Number CDS780202P ;  22) BASIC NEURO PACK, Pack Number CDS780202Q ;  23) BASIC NEURO PACK, Pack Number CDS780202R ;  24) NEURO-LAMI CDS, Pack Number CDS780208D ;  25) NEURO-LAMI CDS, Pack Number CDS780208F ;  26) NEURO CDS, Pack Number CDS780230K;  27) NEURO CDS , Pack Number CDS780230K ;  28) VP SHUNT, Pack Number CDS840193U ;  29) NEURO CDS-LF, Pack Number CDS980853N ;  30) VP SHUNT CDS-LF , Pack Number CDS981084K ;  31) VP SHUNT CDS-LF , Pack Number CDS981084L ;  32) VP SHUNT CDS-LF , Pack Number CDS981084M ;  33) NEURO KIT , Pack Number CDS981327N ;  34) NEURO KIT , Pack Number CDS981327O ;  35) NEURO KIT , Pack Number CDS981327P ;  36) NERVE STIMULATOR, Pack Number CDS981579N ;  37) NEURO MINOR CDS , Pack Number CDS981708K ;  38) VP SHUNT CDS, Pack Number CDS981740F ;  39) VP SHUNT CDS, Pack Number CDS981740J ;  40) VP SHUNT CDS, Pack Number CDS981740K ;  41) VP SHUNT CDS, Pack Number CDS981740KH;  42) MICRO DISC CDS, Pack Number CDS981886P ;  43) MICRO DISC CDS, Pack Number CDS981886R ;  44) MICRO DISC CDS, Pack Number CDS981886S ;  45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ;  46) NEURO CDS , Pack Number CDS982603L ;  47) NEURO CDS , Pack Number CDS982603M ;  48) NEURO CDS , Pack Number CDS982603N ;  49) NEURO SPINE CDS , Pack Number CDS982683Q ;  50) MAJOR NEURO , Pack Number CDS982704K ;  51) MAJOR NEURO , Pack Number CDS982704M ;  52) MAJOR NEURO , Pack Number CDS982704N ;  53) NEURO CDS CHS-LF, Pack Number CDS982745D ;  54) NEURO CDS CHS-LF, Pack Number CDS982745F ;  55) NEURO CDS CHS-LF, Pack Number CDS982745G ;  56) AV SHUNT CDS, Pack Number CDS983098D ;  57) AV SHUNT CDS, Pack Number CDS983098F ;  58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ;  59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ;  60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ;  61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ;  62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ;  63) VP SHUNT, Pack Number CDS983366J ;  64) VP SHUNT, Pack Number CDS983366M ;  65) VP SHUNT, Pack Number CDS983366N ;  66) VP SHUNT, Pack Number CDS983366P ;  67) NEURO CDS-LF, Pack Number CDS983383F ;  68) NEURO CDS-LF, Pack Number CDS983383G ;  69) NEURO CDS-LF, Pack Number CDS983383I ;  70) NEURO CDS-LF, Pack Number CDS983383J ;  71) AV SHUNT CDS, Pack Number CDS983792C ;  72) AV SHUNT CDS, Pack Number CDS983792D ;  73) ANTERIOR NEURO CDS, Pack Number CDS983882C ;  74) ANTERIOR NEURO CDS, Pack Number CDS983882D ;  75) POSTERIOR NEURO CDS , Pack Number CDS983885C ;  76) POSTERIOR NEURO CDS , Pack Number CDS983885D ;  77) POSTERIOR NEURO CDS , Pack Number CDS983885F ;  78) NEURO CDS , Pack Number CDS983981D ;  79) NEURO CDS , Pack Number CDS983981F ;  80) NEURO CDS , Pack Number CDS983981I ;  81) NEURO CDS , Pack Number CDS983981J ;  82) NEURO CDS , Pack Number CDS983981K ;  83) NEURO CDS , Pack Number CDS983981L ;  84) CRANI NEURO CDS , Pack Number CDS984172F ;  85) PUH NEURO EEA CDS , Pack Number CDS984297G ;  86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ;  87) ME (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-3042-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;  2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;  3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ;  4) NEURO CDS , Pack Number CDS780056K ;  5) NEURO CDS , Pack Number CDS780056L ;  6) SHUNT CDS-LF, Pack Number CDS780103K ;  7) NEURO CDS , Pack Number CDS780108T ;  8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ;  9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ;  10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ;  11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ;  12) NEURO CDS , Pack Number CDS780162AA;  13) NEURO CDS , Pack Number CDS780162AB;  14) NEURO CDS , Pack Number CDS780162AC;  15) NEURO CDS , Pack Number CDS780162AD;  16) NEURO CDS , Pack Number CDS780162X ;  17) NEURO CDS , Pack Number CDS780162Y ;  18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ;  19) BASIC NEURO PACK, Pack Number CDS780202L ;  20) BASIC NEURO PACK, Pack Number CDS780202O ;  21) BASIC NEURO PACK, Pack Number CDS780202P ;  22) BASIC NEURO PACK, Pack Number CDS780202Q ;  23) BASIC NEURO PACK, Pack Number CDS780202R ;  24) NEURO-LAMI CDS, Pack Number CDS780208D ;  25) NEURO-LAMI CDS, Pack Number CDS780208F ;  26) NEURO CDS, Pack Number CDS780230K;  27) NEURO CDS , Pack Number CDS780230K ;  28) VP SHUNT, Pack Number CDS840193U ;  29) NEURO CDS-LF, Pack Number CDS980853N ;  30) VP SHUNT CDS-LF , Pack Number CDS981084K ;  31) VP SHUNT CDS-LF , Pack Number CDS981084L ;  32) VP SHUNT CDS-LF , Pack Number CDS981084M ;  33) NEURO KIT , Pack Number CDS981327N ;  34) NEURO KIT , Pack Number CDS981327O ;  35) NEURO KIT , Pack Number CDS981327P ;  36) NERVE STIMULATOR, Pack Number CDS981579N ;  37) NEURO MINOR CDS , Pack Number CDS981708K ;  38) VP SHUNT CDS, Pack Number CDS981740F ;  39) VP SHUNT CDS, Pack Number CDS981740J ;  40) VP SHUNT CDS, Pack Number CDS981740K ;  41) VP SHUNT CDS, Pack Number CDS981740KH;  42) MICRO DISC CDS, Pack Number CDS981886P ;  43) MICRO DISC CDS, Pack Number CDS981886R ;  44) MICRO DISC CDS, Pack Number CDS981886S ;  45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ;  46) NEURO CDS , Pack Number CDS982603L ;  47) NEURO CDS , Pack Number CDS982603M ;  48) NEURO CDS , Pack Number CDS982603N ;  49) NEURO SPINE CDS , Pack Number CDS982683Q ;  50) MAJOR NEURO , Pack Number CDS982704K ;  51) MAJOR NEURO , Pack Number CDS982704M ;  52) MAJOR NEURO , Pack Number CDS982704N ;  53) NEURO CDS CHS-LF, Pack Number CDS982745D ;  54) NEURO CDS CHS-LF, Pack Number CDS982745F ;  55) NEURO CDS CHS-LF, Pack Number CDS982745G ;  56) AV SHUNT CDS, Pack Number CDS983098D ;  57) AV SHUNT CDS, Pack Number CDS983098F ;  58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ;  59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ;  60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ;  61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ;  62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ;  63) VP SHUNT, Pack Number CDS983366J ;  64) VP SHUNT, Pack Number CDS983366M ;  65) VP SHUNT, Pack Number CDS983366N ;  66) VP SHUNT, Pack Number CDS983366P ;  67) NEURO CDS-LF, Pack Number CDS983383F ;  68) NEURO CDS-LF, Pack Number CDS983383G ;  69) NEURO CDS-LF, Pack Number CDS983383I ;  70) NEURO CDS-LF, Pack Number CDS983383J ;  71) AV SHUNT CDS, Pack Number CDS983792C ;  72) AV SHUNT CDS, Pack Number CDS983792D ;  73) ANTERIOR NEURO CDS, Pack Number CDS983882C ;  74) ANTERIOR NEURO CDS, Pack Number CDS983882D ;  75) POSTERIOR NEURO CDS , Pack Number CDS983885C ;  76) POSTERIOR NEURO CDS , Pack Number CDS983885D ;  77) POSTERIOR NEURO CDS , Pack Number CDS983885F ;  78) NEURO CDS , Pack Number CDS983981D ;  79) NEURO CDS , Pack Number CDS983981F ;  80) NEURO CDS , Pack Number CDS983981I ;  81) NEURO CDS , Pack Number CDS983981J ;  82) NEURO CDS , Pack Number CDS983981K ;  83) NEURO CDS , Pack Number CDS983981L ;  84) CRANI NEURO CDS , Pack Number CDS984172F ;  85) PUH NEURO EEA CDS , Pack Number CDS984297G ;  86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ;  87) ME",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3042-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3042-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;  2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;  3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ;  4) NEURO CDS , Pack Number CDS780056K ;  5) NEURO CDS , Pack Number CDS780056L ;  6) SHUNT CDS-LF, Pack Number CDS780103K ;  7) NEURO CDS , Pack Number CDS780108T ;  8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ;  9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ;  10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ;  11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ;  12) NEURO CDS , Pack Number CDS780162AA;  13) NEURO CDS , Pack Number CDS780162AB;  14) NEURO CDS , Pack Number CDS780162AC;  15) NEURO CDS , Pack Number CDS780162AD;  16) NEURO CDS , Pack Number CDS780162X ;  17) NEURO CDS , Pack Number CDS780162Y ;  18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ;  19) BASIC NEURO PACK, Pack Number CDS780202L ;  20) BASIC NEURO PACK, Pack Number CDS780202O ;  21) BASIC NEURO PACK, Pack Number CDS780202P ;  22) BASIC NEURO PACK, Pack Number CDS780202Q ;  23) BASIC NEURO PACK, Pack Number CDS780202R ;  24) NEURO-LAMI CDS, Pack Number CDS780208D ;  25) NEURO-LAMI CDS, Pack Number CDS780208F ;  26) NEURO CDS, Pack Number CDS780230K;  27) NEURO CDS , Pack Number CDS780230K ;  28) VP SHUNT, Pack Number CDS840193U ;  29) NEURO CDS-LF, Pack Number CDS980853N ;  30) VP SHUNT CDS-LF , Pack Number CDS981084K ;  31) VP SHUNT CDS-LF , Pack Number CDS981084L ;  32) VP SHUNT CDS-LF , Pack Number CDS981084M ;  33) NEURO KIT , Pack Number CDS981327N ;  34) NEURO KIT , Pack Number CDS981327O ;  35) NEURO KIT , Pack Number CDS981327P ;  36) NERVE STIMULATOR, Pack Number CDS981579N ;  37) NEURO MINOR CDS , Pack Number CDS981708K ;  38) VP SHUNT CDS, Pack Number CDS981740F ;  39) VP SHUNT CDS, Pack Number CDS981740J ;  40) VP SHUNT CDS, Pack Number CDS981740K ;  41) VP SHUNT CDS, Pack Number CDS981740KH;  42) MICRO DISC CDS, Pack Number CDS981886P ;  43) MICRO DISC CDS, Pack Number CDS981886R ;  44) MICRO DISC CDS, Pack Number CDS981886S ;  45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ;  46) NEURO CDS , Pack Number CDS982603L ;  47) NEURO CDS , Pack Number CDS982603M ;  48) NEURO CDS , Pack Number CDS982603N ;  49) NEURO SPINE CDS , Pack Number CDS982683Q ;  50) MAJOR NEURO , Pack Number CDS982704K ;  51) MAJOR NEURO , Pack Number CDS982704M ;  52) MAJOR NEURO , Pack Number CDS982704N ;  53) NEURO CDS CHS-LF, Pack Number CDS982745D ;  54) NEURO CDS CHS-LF, Pack Number CDS982745F ;  55) NEURO CDS CHS-LF, Pack Number CDS982745G ;  56) AV SHUNT CDS, Pack Number CDS983098D ;  57) AV SHUNT CDS, Pack Number CDS983098F ;  58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ;  59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ;  60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ;  61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ;  62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ;  63) VP SHUNT, Pack Number CDS983366J ;  64) VP SHUNT, Pack Number CDS983366M ;  65) VP SHUNT, Pack Number CDS983366N ;  66) VP SHUNT, Pack Number CDS983366P ;  67) NEURO CDS-LF, Pack Number CDS983383F ;  68) NEURO CDS-LF, Pack Number CDS983383G ;  69) NEURO CDS-LF, Pack Number CDS983383I ;  70) NEURO CDS-LF, Pack Number CDS983383J ;  71) AV SHUNT CDS, Pack Number CDS983792C ;  72) AV SHUNT CDS, Pack Number CDS983792D ;  73) ANTERIOR NEURO CDS, Pack Number CDS983882C ;  74) ANTERIOR NEURO CDS, Pack Number CDS983882D ;  75) POSTERIOR NEURO CDS , Pack Number CDS983885C ;  76) POSTERIOR NEURO CDS , Pack Number CDS983885D ;  77) POSTERIOR NEURO CDS , Pack Number CDS983885F ;  78) NEURO CDS , Pack Number CDS983981D ;  79) NEURO CDS , Pack Number CDS983981F ;  80) NEURO CDS , Pack Number CDS983981I ;  81) NEURO CDS , Pack Number CDS983981J ;  82) NEURO CDS , Pack Number CDS983981K ;  83) NEURO CDS , Pack Number CDS983981L ;  84) CRANI NEURO CDS , Pack Number CDS984172F ;  85) PUH NEURO EEA CDS , Pack Number CDS984297G ;  86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ;  87) ME",
      "text": "The FDA logged enforcement record Z-3042-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA;  2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ;  3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ;  4) NEURO CDS , Pack Number CDS780056K ;  5) NEURO CDS , Pack Number CDS780056L ;  6) SHUNT CDS-LF, Pack Number CDS780103K ;  7) NEURO CDS , Pack Number CDS780108T ;  8) NEURO LAMINECTOMY-LF, Pack Number CDS780109M ;  9) NEURO LAMINECTOMY-LF, Pack Number CDS780109N ;  10) NEURO LAMINECTOMY-LF, Pack Number CDS780109O ;  11) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119T ;  12) NEURO CDS , Pack Number CDS780162AA;  13) NEURO CDS , Pack Number CDS780162AB;  14) NEURO CDS , Pack Number CDS780162AC;  15) NEURO CDS , Pack Number CDS780162AD;  16) NEURO CDS , Pack Number CDS780162X ;  17) NEURO CDS , Pack Number CDS780162Y ;  18) BASIC NEURO PROCEDURE , Pack Number CDS780202K ;  19) BASIC NEURO PACK, Pack Number CDS780202L ;  20) BASIC NEURO PACK, Pack Number CDS780202O ;  21) BASIC NEURO PACK, Pack Number CDS780202P ;  22) BASIC NEURO PACK, Pack Number CDS780202Q ;  23) BASIC NEURO PACK, Pack Number CDS780202R ;  24) NEURO-LAMI CDS, Pack Number CDS780208D ;  25) NEURO-LAMI CDS, Pack Number CDS780208F ;  26) NEURO CDS, Pack Number CDS780230K;  27) NEURO CDS , Pack Number CDS780230K ;  28) VP SHUNT, Pack Number CDS840193U ;  29) NEURO CDS-LF, Pack Number CDS980853N ;  30) VP SHUNT CDS-LF , Pack Number CDS981084K ;  31) VP SHUNT CDS-LF , Pack Number CDS981084L ;  32) VP SHUNT CDS-LF , Pack Number CDS981084M ;  33) NEURO KIT , Pack Number CDS981327N ;  34) NEURO KIT , Pack Number CDS981327O ;  35) NEURO KIT , Pack Number CDS981327P ;  36) NERVE STIMULATOR, Pack Number CDS981579N ;  37) NEURO MINOR CDS , Pack Number CDS981708K ;  38) VP SHUNT CDS, Pack Number CDS981740F ;  39) VP SHUNT CDS, Pack Number CDS981740J ;  40) VP SHUNT CDS, Pack Number CDS981740K ;  41) VP SHUNT CDS, Pack Number CDS981740KH;  42) MICRO DISC CDS, Pack Number CDS981886P ;  43) MICRO DISC CDS, Pack Number CDS981886R ;  44) MICRO DISC CDS, Pack Number CDS981886S ;  45) NEURO BACK CDS QVH-LF , Pack Number CDS982527F ;  46) NEURO CDS , Pack Number CDS982603L ;  47) NEURO CDS , Pack Number CDS982603M ;  48) NEURO CDS , Pack Number CDS982603N ;  49) NEURO SPINE CDS , Pack Number CDS982683Q ;  50) MAJOR NEURO , Pack Number CDS982704K ;  51) MAJOR NEURO , Pack Number CDS982704M ;  52) MAJOR NEURO , Pack Number CDS982704N ;  53) NEURO CDS CHS-LF, Pack Number CDS982745D ;  54) NEURO CDS CHS-LF, Pack Number CDS982745F ;  55) NEURO CDS CHS-LF, Pack Number CDS982745G ;  56) AV SHUNT CDS, Pack Number CDS983098D ;  57) AV SHUNT CDS, Pack Number CDS983098F ;  58) ZALE V-P SHUNT CDS, Pack Number CDS983186D ;  59) ZALE V-P SHUNT CDS, Pack Number CDS983186F ;  60) ZALE V-P SHUNT CDS, Pack Number CDS983186G ;  61) ZALE V-P SHUNT CDS, Pack Number CDS983186I ;  62) ZALE V-P SHUNT CDS, Pack Number CDS983186J ;  63) VP SHUNT, Pack Number CDS983366J ;  64) VP SHUNT, Pack Number CDS983366M ;  65) VP SHUNT, Pack Number CDS983366N ;  66) VP SHUNT, Pack Number CDS983366P ;  67) NEURO CDS-LF, Pack Number CDS983383F ;  68) NEURO CDS-LF, Pack Number CDS983383G ;  69) NEURO CDS-LF, Pack Number CDS983383I ;  70) NEURO CDS-LF, Pack Number CDS983383J ;  71) AV SHUNT CDS, Pack Number CDS983792C ;  72) AV SHUNT CDS, Pack Number CDS983792D ;  73) ANTERIOR NEURO CDS, Pack Number CDS983882C ;  74) ANTERIOR NEURO CDS, Pack Number CDS983882D ;  75) POSTERIOR NEURO CDS , Pack Number CDS983885C ;  76) POSTERIOR NEURO CDS , Pack Number CDS983885D ;  77) POSTERIOR NEURO CDS , Pack Number CDS983885F ;  78) NEURO CDS , Pack Number CDS983981D ;  79) NEURO CDS , Pack Number CDS983981F ;  80) NEURO CDS , Pack Number CDS983981I ;  81) NEURO CDS , Pack Number CDS983981J ;  82) NEURO CDS , Pack Number CDS983981K ;  83) NEURO CDS , Pack Number CDS983981L ;  84) CRANI NEURO CDS , Pack Number CDS984172F ;  85) PUH NEURO EEA CDS , Pack Number CDS984297G ;  86) PUH NEURO VP SHUNT CDS, Pack Number CDS984323G ;  87) ME — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: 00-401327AA, Lot Number 20AMA256 ;  00-401327AA, Lot Number 20AMC142 ;  00-401327AA, Lot Number 20BMB258 ;  00-401327AA, Lot Number 20DMB109 ;  00-401327AA, Lot Number 20GMB772 ;  00-401327AA, Lot Number 20HMC035 ;  00-401327AA, Lot Number 20JMA910 ;  00-401327AA, Lot Number 20JMB656 ;  00-401327AA, Lot Number 21CMA167 ;  00-401327AA, Lot Number 21EMB860 ;  00-401327AA, Lot Number 21FMC472 ;  00-401327AA, Lot Number 21GMF286 ;  00-401327AA, Lot Number 21HME693 ;  00-401327AA, Lot Number 21IMC842 ;  00-401327AA, Lot Number 21KMB315 ;  00-401594R , Lot Number 19LDA473 ;  00-401594R , Lot Number 20ADB972 ;  00-401594R , Lot Number 20CDC521 ;  00-401594R , Lot Number 20EDB836 ;  00-401594R , Lot Number 20HDA321 ;  00-401594R , Lot Number 21CDB556 ;  00-401594R , Lot Number 21EDA344 ;  00-401808S , Lot Number 21GBR684 ;  00-401808S , Lot Number 21IBB505 ;  00-401808S , Lot Number 21JBD593 ;  00-401808S , Lot Number 21JBD594 ;  00-401808S , Lot Number 21JBD596 ;  00-401808S , Lot Number 22ABS576 ;  00-401808S , Lot Number 19ABL630 ;  00-401808S , Lot Number 22NBA002 ;  00-401808S , Lot Number 19BBJ217 ;  00-401808S , Lot Number 22OBB643 ;  00-401808S , Lot Number 19DBK655 ;  00-401808S , Lot Number 22FBO951 ;  00-401808S , Lot Number 19FBI621 ;  00-401808S , Lot Number 19FBV633 ;  00-401808S , Lot Number 22HBR194 ;  00-401808S , Lot Number 22IBG899 ;  00-401808S , Lot Number 19HBL271 ;  00-401808S , Lot Number 22JBH625 ;  00-401808S , Lot Number 19IBG849 ;  00-401808S , Lot Number 22KBP137 ;  00-401808S , Lot Number 19IBZ700 ;  00-401808S , Lot Number 22LBN374 ;  00-401808S , Lot Number 19VBC278 ;  00-401808S , Lot Number 19KBQ992 ;  00-401808S , Lot Number 23CBC166 ;  00-401808S , Lot Number 19LBK455 ;  00-401808S , Lot Number 23CBW993 ;  00-401808S , Lot Number 23EBE204 ;  00-401808S , Lot Number 23EBF240 ;  00-401808S , Lot Number 20CBH056 ;  00-401808S , Lot Number 23GBN716 ;  00-401808S , Lot Number 20CBY951 ;  00-401808S , Lot Number 23HBG573 ;  00-401808S , Lot Number 20FBB585 ;  00-401808S , Lot Number 20FBE238 ;  00-401808S , Lot Number 20FBF231 ;  00-401808S , Lot Number 23JBC088 ;  00-401808S , Lot Number 20GBJ388 ;  00-401808S , Lot Number 23KBM084 ;  00-401808S , Lot Number 20JBC354 ;  00-401808S , Lot Number 20LBD734 ;  00-401808S , Lot Number 21CBX182 ;  CDS780056K , Lot Number 19BBQ112 ;  CDS780056K , Lot Number 19FBQ838 ;  CDS780056K , Lot Number 19HBN954 ;  CDS780056K , Lot Number 19JBJ354 ;  CDS780056K , Lot Number 19KBF418 ;  CDS780056K , Lot Number 20BBF089 ;  CDS780056K , Lot Number 20OBA309 ;  CDS780056K , Lot Number 20DBL328 ;  CDS780056K , Lot Number 20GBL494 ;  CDS780056K , Lot Number 20GBV115 ;  CDS780056K , Lot Number 20KBS804 ;  CDS780056K , Lot Number 20WBI356 ;  CDS780056K , Lot Number 21DBU610 ;  CDS780056L , Lot Number 21IBV394 ;  CDS780056L , Lot Number 21KBG946 ;  CDS780103K , Lot Number 22OBI238 ;  CDS780103K , Lot Number 22FBF458 ;  CDS780103K , Lot Number 22HBF971 ;  CDS780103K , Lot Number 22HBF972 ;  CDS780103K , Lot Number 22IBQ334 ;  CDS780103K , Lot Number 22JBR855 ;  CDS780103K , Lot Number 22LBB223 ;  CDS780103K , Lot Number 23BBD147 ;  CDS780103K , Lot Number 23FBQ301 ;  CDS780103K , Lot Number 23GBE098 ;  CDS780103K , Lot Number 23GBT769 ;  CDS780103K , Lot Number 23IBB510 ;  CDS780103K , Lot Number 23JBG685 ;  CDS780103K , Lot Number 23LBR311 ;  CDS780103K , Lot Number 23LBV808 ;  CDS780103K , Lot Number 24CBE995 ;  CDS780108T , Lot Number 19DLA065 ;  CDS780108T , Lot Number 19DLA501 ;  CDS780108T , Lot Number 19DLA665 ;  CDS780108T , Lot Number 19FLA394 ;  CDS780108T , Lot Number 19GLA142 ;  CDS780108T , Lot Number 19GLA202 ;  CDS780108T , Lot Number 19GLA261 ;  CDS780108T , Lot Number 19HLA111 ;  CDS780108T , Lot Number 19HLA402 ;  CDS780108T , Lot Number 19ILA293 ;  CDS780108T , Lot Number 19JLA050 ;  CDS780108T , Lot Number 19JLA667 ;  CDS780108T , Lot Number 19KLA463 ;  CDS780108T , Lot Number 20ALA303 ;  CDS780108T , Lot Number 20BLA407 ;  CDS780109M , Lot Number 19CBI751 ;  CDS780109M , Lot Number 19CBR419 ;  CDS780109N , Lot Number 19EBU235 ;  CDS780109N , Lot Number 19FBO209 ;  CDS780109N , Lot Number 19HBD224 ;  CDS780109N , Lot Number 19JBT649 ;  CDS780109N , Lot Number 19KBY989 ;  CDS780109N , Lot Number 20ABT942 ;  CDS780109N , Lot Number 20CBY395 ;  CDS780109O , Lot Number 21HBM967 ;  CDS780109O , Lot Number 21KBC808 ;  CDS780109O , Lot Number 22BBC815 ;  CDS780109O , Lot Number 22OBA987 ;  CDS780109O , Lot Number 22EBE862 ;  CDS780109O , Lot Number 22FBI951 ;  CDS780109O , Lot Number 22GBK671 ;  CDS780109O , Lot Number 22HBZ276 ;  CDS780109O , Lot Number 22IBK666 ;  CDS780109O , Lot Number 22KBD840 ;  CDS780109O , Lot Number 23ABG956 ;  CDS780109O , Lot Number 23CBO553 ;  CDS780109O , Lot Number 23DBB223 ;  CDS780109O , Lot Number 23EBP966 ;  CDS780109O , Lot Number 23FBL915 ;  CDS780109O , Lot Number 23HBL622 ;  CDS780109O , Lot Number 23HBO324 ;  CDS780109O , Lot Number 23IBO480 ;  CDS780109O , Lot Number 20HBG092 ;  CDS780109O , Lot Number 20HBT149 ;  CDS780109O , Lot Number 20WBE680 ;  CDS780109O , Lot Number 20LBP961 ;  CDS780109O , Lot Number 21DBB965 ;  CDS780109O , Lot Number 21DBN004 ;  CDS780109O , Lot Number 21FBD640 ;  CDS780119T , Lot Number 19DBE959 ;  CDS780119T , Lot Number 19DBT828 ;  CDS780119T , Lot Number 19EBV096 ;  CDS780119T , Lot Number 19GBI935 ;  CDS780119T , Lot Number 19HBH508 ;  CDS780119T , Lot Number 19JBJ656 ;  CDS780119T , Lot Number 20BBD324 ;  CDS780119T , Lot Number 20CBP243 ;  CDS780119T , Lot Number 20DBK808 ;  CDS780119T , Lot Number 20DBQ069 ;  CDS780119T , Lot Number 20EBU829 ;  CDS780162AA, Lot Number 20BBO888 ;  CDS780162AA, Lot Number 20BBQ352 ;  CDS780162AA, Lot Number 20FBR735 ;  CDS780162AB, Lot Number 20GBF853 ;  CDS780162AC, Lot Number 20HBE537 ;  CDS780162AC, Lot Number 20IBB263 ;  CDS780162AC, Lot Number 20JBB811 ;  CDS780162AC, Lot Number 20KBA268 ;  CDS780162AC, Lot Number 20LBM232 ;  CDS780162AC, Lot Number 21ABA833 ;  CDS780162AD, Lot Number 21GBS609 ;  CDS780162AD, Lot Number 21HBB525 ;  CDS780162AD, Lot Number 21ABU170 ;  CDS780162AD, Lot Number 21BBQ045 ;  CDS780162AD, Lot Number 21DBD059 ;  CDS780162AD, Lot Number 21DBS617 ;  CDS780162X , Lot Number 19ABX591 ;  CDS780162X , Lot Number 19BBM085 ;  CDS780162X , Lot Number 19CBM932 ;  CDS780162X , Lot Number 19EBF768 ;  CDS780162X , Lot Number 19EBU016 ;  CDS780162X , Lot Number 19EBY613 ;  CDS780162X , Lot Number 19FBI652 ;  CDS780162X , Lot Number 19GBV765 ;  CDS780162Y , Lot Number 19RBB546 ;  CDS780162Y , Lot Number 19HBC545 ;  CDS780162Y , Lot Number 19HBD425 ;  CDS780162Y , Lot Number 19JBG849 ;  CDS780162Y , Lot Number 19VBH579 ;  CDS780162Y , Lot Number 19LBO181 ;  CDS780202K , Lot Number 19BBF898 ;  CDS780202K , Lot Number 19EBH536 ;  CDS780202K , Lot Number 19EBW699 ;  CDS780202K , Lot Number 19IBZ537 ;  CDS780202K , Lot Number 19KBK182 ;  CDS780202K , Lot Number 20BBE556 ;  CDS780202K , Lot Number 20EBK692 ;  CDS780202K , Lot Number 20HBD633 ;  CDS780202K , Lot Number 20HBW511 ;  CDS780202K , Lot Number 20IBM805 ;  CDS780202K , Lot Number 20JBP710 ;  CDS780202L , Lot Number 20KBL342 ;  CDS780202L , Lot Number 21ABJ200 ;  CDS780202L , Lot Number 21CBO838 ;  CDS780202L , Lot Number 21DBH721 ;  CDS780202L , Lot Number 21FBA775 ;  CDS780202O , Lot Number 21KBK282 ;  CDS780202P , Lot Number 22BMG694 ;  CDS780202P , Lot Number 22BMH432 ;  CDS780202P , Lot Number 22DME085 ;  CDS780202P , Lot Number 22FMD852 ;  CDS780202P , Lot Number 22FMH471 ;  CDS780202P , Lot Number 22GME200 ;  CDS780202P , Lot Number 22IMA512 ;  CDS780202P , Lot Number 22IMA513 ;  CDS780202P , Lot Number 22LMA065 ;  CDS780202Q , Lot Number 22LMA225 ;  CDS780202Q , Lot Number 23DME052 ;  CDS780202Q , Lot Number 23EME852 ;  CDS780202R , Lot Number 23FMI343 ;  CDS780202R , Lot Number 23HMA280 ;  CDS780202R , Lot Number 23HMF567 ;  CDS780202R , Lot Number 23IMG471 ;  CDS780202R , Lot Number 23LMG063 ;  CDS780208D , Lot Number 19BBE281 ;  CDS780208D , Lot Number 19CBW813 ;  CDS780208D , Lot Number 19EBJ193 ;  CDS780208D , Lot Number 19QBB506 ;  CDS780208D , Lot Number 19FBY437 ;  CDS780208D , Lot Number 19HBK572 ;  CDS780208D , Lot Number 19JBU460 ;  CDS780208D , Lot Number 20ABA580 ;  CDS780208D , Lot Number 20DBF942 ;  CDS780208D , Lot Number 20GBD855 ;  CDS780208D , Lot Number 21ABD250 ;  CDS780208F , Lot Number 22ABH903 ;  CDS780208F , Lot Number 22BBQ627 ;  CDS780208F , Lot Number 22DBL468 ;  CDS780208F , Lot Number 22EBM543 ;  CDS780208F , Lot Number 22HBH464 ;  CDS780208F , Lot Number 22IBN540 ;  CDS780208F , Lot Number 22KBM775 ;  CDS780208F , Lot Number 23ABM574 ;  CDS780208F , Lot Number 23ABU440 ;  CDS780208F , Lot Number 21FBD429 ;  CDS780230K, Lot Number 24CMH800;  CDS780230K , Lot Number 21EME444 ;  CDS780230K , Lot Number 21GMD475 ;  CDS780230K , Lot Number 21HMG159 ;  CDS780230K , Lot Number 22AMB644 ;  CDS780230K , Lot Number 22AME418 ;  CDS780230K , Lot Number 22CMB893 ;  CDS780230K , Lot Number 22EMF683 ;  CDS780230K , Lot Number 23BMF118 ;  CDS780230K , Lot Number 23DMB891 ;  CDS780230K , Lot Number 23DMG955 ;  CDS780230K , Lot Number 23EMF336 ;  CDS780230K , Lot Number 23EMG749 ;  CDS780230K , Lot Number 23GMD696 ;  CDS780230K , Lot Number 23HMF568 ;  CDS780230K , Lot Number 24AME651 ;  CDS780230K , Lot Number 19BKA866 ;  CDS780230K , Lot Number 19DKB314 ;  CDS780230K , Lot Number 19GKA073 ;  CDS780230K , Lot Number 19IKC036 ;  CDS780230K , Lot Number 20CKA869 ;  CDS780230K , Lot Number 20EKB233 ;  CDS780230K , Lot Number 20FKA792 ;  CDS780230K , Lot Number 20HKA071 ;  CDS780230K , Lot Number 20IKA278 ;  CDS780230K , Lot Number 20IKA844 ;  CDS780230K , Lot Number 20KKA255 ;  CDS780230K , Lot Number 21CKA528 ;  CDS840193U , Lot Number 19BBR999 ;  CDS840193U , Lot Number 19GBF781 ;  CDS840193U , Lot Number 19VBG349 ;  CDS840193U , Lot Number 19LBI200 ;  CDS840193U , Lot Number 19LBO263 ;  CDS840193U , Lot Number 20DBT061 ;  CDS840193U , Lot Number 20FBF962 ;  CDS840193U , Lot Number 20GBG150 ;  CDS840193U , Lot Number 20KBU635 ;  CDS840193U , Lot Number 21BBD218 ;  CDS980853N , Lot Number 19ADB477 ;  CDS980853N , Lot Number 19BDC358 ;  CDS980853N , Lot Number 19CDC680 ;  CDS980853N , Lot Number 19DDA744 ;  CDS980853N , Lot Number 19EDA991 ;  CDS980853N , Lot Number 19FDD001 ;  CDS980853N , Lot Number 19GDB395 ;  CDS980853N , Lot Number 19KDA244 ;  CDS980853N , Lot Number 20ADA320 ;  CDS980853N , Lot Number 20BDA509 ;  CDS980853N , Lot Number 20BDC708 ;  CDS980853N , Lot Number 20DDB465 ;  CDS980853N , Lot Number 20FDB972 ;  CDS980853N , Lot Number 20GDC217 ;  CDS981084K , Lot Number 19CKD398 ;  CDS981084K , Lot Number 19EKB258 ;  CDS981084L , Lot Number 19FKC140 ;  CDS981084L , Lot Number 19HKB670 ;  CDS981084L , Lot Number 19JKA279 ;  CDS981084L , Lot Number 19KKB562 ;  CDS981084L , Lot Number 19LKA703 ;  CDS981084L , Lot Number 20AKA342 ;  CDS981084L , Lot Number 20BKB585 ;  CDS981084L , Lot Number 20DKB238 ;  CDS981084L , Lot Number 20FKA822 ;  CDS981084L , Lot Number 20GKB549 ;  CDS981084M , Lot Number 21GMF555 ;  CDS981084M , Lot Number 21JMA414 ;  CDS981084M , Lot Number 21JMA828 ;  CDS981084M , Lot Number 22AMC101 ; 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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
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      "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-3042-2024&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-3042-2024&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-3042-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3042-2024 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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        "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-3042-2024&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-3042-2024&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-3042-2024/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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            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
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 CDS983885D , Lot Number 21JBX843 ;  CDS983885D , Lot Number 22DBB159 ;  CDS983885D , Lot Number 22EBF942 ;  CDS983885D , Lot Number 22FBH437 ;  CDS983885D , Lot Number 22FBX184 ;  CDS983885D , Lot Number 22JBJ163 ;  CDS983885D , Lot Number 22KBS655 ;  CDS983885D , Lot Number 23ABL469 ;  CDS983885D , Lot Number 23ABN789 ;  CDS983885D , Lot Number 23CBI556 ;  CDS983885D , Lot Number 23EBK997 ;  CDS983885D , Lot Number 23EBU951 ;  CDS983885D , Lot Number 23FBL260 ;  CDS983885D , Lot Number 21CBT329 ;  CDS983885D , Lot Number 21FBE881 ;  CDS983885D , Lot Number 21FBE882 ;  CDS983885D , Lot Number 22CLA523 ;  CDS983885F , Lot Number 23KBU576 ;  CDS983885F , Lot Number 23KBU834 ;  CDS983885F , Lot Number 24ABB735 ;  CDS983981D , Lot Number 19CBD170 ;  CDS983981F , Lot Number 19DBP051 ;  CDS983981F , Lot Number 19GBL027 ;  CDS983981F , Lot Number 19JBT602 ;  CDS983981F , Lot Number 19VBA665 ;  CDS983981F , Lot Number 19VBC048 ;  CDS983981I , Lot Number 20CBF484 ;  CDS983981J , Lot Number 21GBE942 ; 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 CDS984172F , Lot Number 20HBU118 ;  CDS984172F , Lot Number 20IBH561 ;  CDS984172F , Lot Number 20JBR070 ;  CDS984172F , Lot Number 21EBI482 ;  CDS984172F , Lot Number 21EBK805 ;  CDS984297G , Lot Number 21HBC361 ;  CDS984297G , Lot Number 21HBC545 ;  CDS984297G , Lot Number 21JBA878 ;  CDS984297G , Lot Number 21JBF855 ;  CDS984297G , Lot Number 22ABB092 ;  CDS984297G , Lot Number 22BBJ452 ;  CDS984297G , Lot Number 22BBJ453 ;  CDS984297G , Lot Number 22GBI993 ;  CDS984297G , Lot Number 22GBT350 ;  CDS984297G , Lot Number 22IBR909 ;  CDS984297G , Lot Number 22JBU173 ;  CDS984297G , Lot Number 23ABO242 ;  CDS984297G , Lot Number 23ABP041 ;  CDS984297G , Lot Number 23BBU266 ;  CDS984297G , Lot Number 20BBK648 ;  CDS984297G , Lot Number 20DBK821 ;  CDS984297G , Lot Number 20EBC094 ;  CDS984297G , Lot Number 20GBC958 ;  CDS984297G , Lot Number 20JBD419 ;  CDS984297G , Lot Number 20JBI324 ;  CDS984297G , Lot Number 20JBS770 ;  CDS984297G , Lot Number 20LBM854 ;  CDS984297G , Lot Number 21CBU578 ;  CDS984297G , Lot Number 21DBP519 ;  CDS984297G , Lot Number 21EBK875 ;  CDS984323G , Lot Number 22IBS382 ;  CDS984323G , Lot Number 22JBA696 ;  CDS984323G , Lot Number 22KBW048 ;  CDS984323G , Lot Number 22LBN379 ;  CDS984323G , Lot Number 23BBI976 ;  CDS984323G , Lot Number 23CBO815 ;  CDS984323G , Lot Number 23DBF796 ;  CDS984323G , Lot Number 23DBQ245 ;  CDS984391S , Lot Number 19ABH340 ;  CDS984391S , Lot Number 19ABH341 ;  CDS984391S , Lot Number 19BBH126 ;  CDS984391S , Lot Number 19BBU494 ;  CDS984391S , Lot Number 19EBL578 ;  CDS984391S , Lot Number 19SBF200 ;  CDS984391S , Lot Number 19HBJ023 ;  CDS984391S , Lot Number 19TBA428 ;  CDS984391S , Lot Number 19IBX394 ;  CDS984391S , Lot Number 19VBD038 ;  CDS984391S , Lot Number 19KBR963 ;  CDS984391S , Lot Number 20BBM841 ;  CDS984391S , Lot Number 20CBL974 ;  CDS984391T , Lot Number 21FBR344 ;  CDS984391T , Lot Number 21IBJ265 ;  CDS984391T , Lot Number 21JBO019 ;  CDS984391T , Lot Number 21KBC810 ;  CDS984391T , Lot Number 21LBU072 ;  CDS984391T , Lot Number 22CBJ564 ;  CDS984391T , Lot Number 22DBO564 ;  CDS984391T , Lot Number 22FBD510 ;  CDS984391T , Lot Number 22FBF407 ;  CDS984391T , Lot Number 22FBF408 ;  CDS984391T , Lot Number 22GBK211 ;  CDS984391T , Lot Number 22HBX020 ;  CDS984391T , Lot Number 22IBV462 ;  CDS984391T , Lot Number 22KBS597 ;  CDS984391T , Lot Number 23ABC403 ;  CDS984391T , Lot Number 23BBS466 ;  CDS984391T , Lot Number 20DBL050 ;  CDS984391T , Lot Number 20GBQ745 ;  CDS984391T , Lot Number 20JBP568 ;  CDS984391T , Lot Number 20KBJ014 ;  CDS984391T , Lot Number 20WBC643 ;  CDS984391T , Lot Number 21CBT340 ;  CDS984391T , Lot Number 21DBE161 ;  CDS984496I , Lot Number 22DBS440 ;  CDS984496I , Lot Number 22DBT289 ;  CDS984496I , Lot Number 22FBW276 ;  CDS984496I , Lot Number 22GBH595 ;  CDS984564D , Lot Number 19CBA365 ;  CDS984564F , Lot Number 19FBZ882 ;  CDS984564F , Lot Number 20IBE932 ;  CDS984651B , Lot Number 21JBJ734 ;  CDS984651B , Lot Number 21JBV996 ;  CDS984651B , Lot Number 19ABN004 ;  CDS984651B , Lot Number 19BBF927 ;  CDS984651B , Lot Number 19CBT725 ;  CDS984651B , Lot Number 19EBC021 ;  CDS984651B , Lot Number 19FBY917 ;  CDS984651B , Lot Number 19GBD803 ;  CDS984651B , Lot Number 19GBL163 ;  CDS984651B , Lot Number 19KBK150 ;  CDS984651B , Lot Number 19KBL058 ;  CDS984651B , Lot Number 19LBX903 ;  CDS984651B , Lot Number 20CBD248 ;  CDS984651B , Lot Number 20CBW914 ;  CDS984651B , Lot Number 20DBT443 ;  CDS984651B , Lot Number 20IBE700 ;  CDS984651B , Lot Number 20JBY194 ;  CDS984651B , Lot Number 20XBC449 ;  CDS984651B , Lot Number 21CBI427 ;  CDS984651B , Lot Number 21CBL027 ;  CDS985020D , Lot Number 19ABM830 ;  CDS985020D , Lot Number 19BBI630 ;  CDS985020D , Lot Number 19BBN779 ;  CDS985020D , Lot Number 19BBT876 ;  CDS985020D , Lot Number 19FBI190 ;  CDS985020D , Lot Number 19HBD486 ;  CDS985020D , Lot Number 19JBW484 ;  CDS985020D , Lot Number 19KBL960 ;  CDS985020D , Lot Number 20ABA050 ;  CDS985246I , Lot Number 19AKB483 ;  CDS985246I , Lot Number 19BKB687 ;  CDS985246I , Lot Number 19CKD529 ;  CDS985246I , Lot Number 19EKA113 ;  CDS985246I , Lot Number 19FKC363 ;  CDS985246I , Lot Number 19GKC687 ;  CDS985246I , Lot Number 19JKA835 ;  CDS985246J , Lot Number 21DME353 ;  CDS985246J , Lot Number 21EME270 ;  CDS985246J , Lot Number 21GME797 ;  CDS985246J , Lot Number 21JMD713 ;  CDS985246J , Lot Number 21JME074 ;  CDS985246J , Lot Number 21KMH120 ;  CDS985246J , Lot Number 21LMA027 ;  CDS985246J , Lot Number 21LMF255 ;  CDS985246J , Lot Number 22FMA322 ;  CDS985246J , Lot Number 22GMB333 ;  CDS985246J , Lot Number 22HMB295 ;  CDS985246J , Lot Number 22IMB860 ;  CDS985246J , Lot Number 22JMC335 ;  CDS985246J , Lot Number 22KMH073 ;  CDS985246J , Lot Number 22LMD214 ;  CDS985246J , Lot Number 22LME459 ;  CDS985246J , Lot Number 23BMA474 ;  CDS985246J , Lot Number 23BMH175 ;  CDS985246J , Lot Number 19LKA813 ;  CDS985246J , Lot Number 20BKB661 ;  CDS985246J , Lot Number 20CKA900 ;  CDS985246J , Lot Number 20EKB756 ;  CDS985246J , Lot Number 20HKB295 ;  CDS985246J , Lot Number 20JKA916 ;  CDS985246J , Lot Number 21CKA026 ;  CDS985246K , Lot Number 23CMA813 ;  CDS985246K , Lot Number 23CMF672 ;  CDS985246K , Lot Number 23FMB824 ;  CDS985246K , Lot Number 23FMF215 ;  CDS985246K , Lot Number 23GMB417 ;  CDS985246K , Lot Number 23IMF250 ;  CDS985246K , Lot Number 23KMJ249 ;  CDS985246K , Lot Number 23LMD819 ;  CDS985289, Lot Number 21GBE846 ;  CDS985289, Lot Number 21IBO741 ;  CDS985289, Lot Number 21VBD126 ;  CDS985289, Lot Number 19ABQ388 ;  CDS985289, Lot Number 22CBS182 ;  CDS985289, Lot Number 19CBM495 ;  CDS985289, Lot Number 19DBJ999 ;  CDS985289, Lot Number 22FBM615 ;  CDS985289, Lot Number 19FBG059 ;  CDS985289, Lot Number 22IBD861 ;  CDS985289, Lot Number 22IBF823 ;  CDS985289, Lot Number 22JBH363 ;  CDS985289, Lot Number 19IBZ094 ;  CDS985289, Lot Number 23ABD309 ;  CDS985289, Lot Number 19LBH058 ;  CDS985289, Lot Number 23CBW370 ;  CDS985289, Lot Number 23FBC219 ;  CDS985289, Lot Number 20CBW891 ;  CDS985289, Lot Number 20FBU792 ;  CDS985289, Lot Number 20IBD354 ;  CDS985289, Lot Number 20LBG020 ;  CDS985289, Lot Number 21CBE526 ;  CDS985289A , Lot Number 23HBS924 ;  CDS985289A , Lot Number 23LBB378 ;  CDS985289A , Lot Number 23LBQ385 ;  CDS985351, Lot Number 21GBH372 ;  CDS985351, Lot Number 21GBH373 ;  CDS985351, Lot Number 21GBK370 ;  CDS985351, Lot Number 21KBA540 ;  CDS985351, Lot Number 21KBV815 ;  CDS985351, Lot Number 22ABW938 ;  CDS985351, Lot Number 19ABS413 ;  CDS985351, Lot Number 19BBR809 ;  CDS985351, Lot Number 19CBO109 ;  CDS985351, Lot Number 22DBG801 ;  CDS985351, Lot Number 22FBE892 ;  CDS985351, Lot Number 19EBU832 ;  CDS985351, Lot Number 22FBV571 ;  CDS985351, Lot Number 22GBT670 ;  CDS985351, Lot Number 19GBE547 ;  CDS985351, Lot Number 19TBD981 ;  CDS985351, Lot Number 22LBB561 ;  CDS985351, Lot Number 19JBX089 ;  CDS985351, Lot Number 19LBI223 ;  CDS985351, Lot Number 20BBQ482 ;  CDS985351, Lot Number 20DBL304 ;  CDS985351, Lot Number 20HBA708 ;  CDS985351, Lot Number 20HBX532 ;  CDS985351, Lot Number 20KBB647 ;  CDS985351, Lot Number 21ABP687 ;  CDS985351, Lot Number 21BBK099 ;  CDS985386B , Lot Number 21FBN810 ;  CDS985386B , Lot Number 21GBP372 ;  CDS985386B , Lot Number 21JBP600 ;  CDS985386B , Lot Number 21KBV749 ;  CDS985386B , Lot Number 19BBG611 ;  CDS985386B , Lot Number 22CBS299 ;  CDS985386B , Lot Number 22OBM474 ;  CDS985386B",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}