{
  "@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-3002-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NECK, Pack Number CDS980809K ;  23) EENT-HEAD AND NECK, Pack Number CDS980809L ;  24) EENT-HEAD AND NECK, Pack Number CDS980809M ;  25) FESS PROCEDURE, Pack Number CDS981185B ;  26) CDS981571P, Pack Number CDS981571P ;  27) SINUS CDS-LF, Pack Number CDS981692J ;  28) EAR CDS , Pack Number CDS981985F ;  29) MAJOR EAR , Pack Number CDS982016Q ;  30) MAJOR EAR , Pack Number CDS982016R ;  31) MAJOR EAR , Pack Number CDS982016S ;  32) MAJOR EAR , Pack Number CDS982016T ;  33) SINUS , Pack Number CDS982020O ;  34) SINUS , Pack Number CDS982020P ;  35) SINUS , Pack Number CDS982020R ;  36) NASAL/SEPTAL, Pack Number CDS982049M;  37) NASAL/SEPTAL, Pack Number CDS982049O;  38) T&A CDS-LF, Pack Number CDS982091I ;  39) EAR-EENT CDS, Pack Number CDS982307F ;  40) EAR-EENT CDS, Pack Number CDS982307G ;  41) EAR-EENT CDS, Pack Number CDS982307J ;  42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;  43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;  44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;  45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;  46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;  47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;  48) EAR CDS-LF, Pack Number CDS982612B ;  49) T AND A CDS MRH , Pack Number CDS982622L ;  50) CAROTID , Pack Number CDS982638J ;  51) NASAL CDS , Pack Number CDS982655C ;  52) NASAL CDS , Pack Number CDS982655D ;  53) NASAL CDS , Pack Number CDS982655F ;  54) NECK THYROID, Pack Number CDS982692M ;  55) NECK THYROID, Pack Number CDS982692N ;  56) NECK THYROID, Pack Number CDS982692O ;  57) TYMPANOPLASTY , Pack Number CDS982720N ;  58) TYMPANOPLASTY , Pack Number CDS982720P ;  59) TYMPANOPLASTY , Pack Number CDS982720Q ;  60) TYMPANOPLASTY , Pack Number CDS982720R ;  61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;  62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;  63) SINUS CDS-1 , Pack Number CDS982901F ;  64) MIDDLE EAR CDS, Pack Number CDS982938J ;  65) MIDDLE EAR CDS, Pack Number CDS982938K ;  66) MIDDLE EAR CDS, Pack Number CDS982938L ;  67) MIDDLE EAR CDS, Pack Number CDS982938O ;  68) SMR/RHINO CDS , Pack Number CDS982939L ;  69) SMR/RHINO CDS , Pack Number CDS982939M ;  70) SMR/RHINO CDS , Pack Number CDS982939N ;  71) SMR/RHINO CDS , Pack Number CDS982939Q ;  72) SMR/RHINO CDS , Pack Number CDS982939R ;  73) SMR/RHINO CDS , Pack Number CDS982939S ;  74) T&A CDS , Pack Number CDS982944J ;  75) T&A CDS , Pack Number CDS982944K ;  76) MINOR EAR , Pack Number CDS982989K ;  77) MINOR EAR , Pack Number CDS982989L ;  78) MINOR EAR , Pack Number CDS982989M ;  79) MINOR EAR , Pack Number CDS982989N ;  80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;  81) ENT CDS , Pack Number CDS983035J ;  82) ENT CDS , Pack Number CDS983035L ;  83) ENT CDS , Pack Number CDS983035M ;  84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;  85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;  86) HEAD & NECK CDS , Pack Number CDS983126B ;  87) HEAD & NECK CDS , Pack Number CDS983126C ;  88) CAROTID CDS-",
  "description": "FDA recall Z-3002-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NECK, Pack Number CDS980809K ;  23) EENT-HEAD AND NECK, Pack Number CDS980809L ;  24) EENT-HEAD AND NECK, Pack Number CDS980809M ;  25) FESS PROCEDURE, Pack Number CDS981185B ;  26) CDS981571P, Pack Number CDS981571P ;  27) SINUS CDS-LF, Pack Number CDS981692J ;  28) EAR CDS , Pack Number CDS981985F ;  29) MAJOR EAR , Pack Number CDS982016Q ;  30) MAJOR EAR , Pack Number CDS982016R ;  31) MAJOR EAR , Pack Number CDS982016S ;  32) MAJOR EAR , Pack Number CDS982016T ;  33) SINUS , Pack Number CDS982020O ;  34) SINUS , Pack Number CDS982020P ;  35) SINUS , Pack Number CDS982020R ;  36) NASAL/SEPTAL, Pack Number CDS982049M;  37) NASAL/SEPTAL, Pack Number CDS982049O;  38) T&A CDS-LF, Pack Number CDS982091I ;  39) EAR-EENT CDS, Pack Number CDS982307F ;  40) EAR-EENT CDS, Pack Number CDS982307G ;  41) EAR-EENT CDS, Pack Number CDS982307J ;  42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;  43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;  44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;  45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;  46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;  47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;  48) EAR CDS-LF, Pack Number CDS982612B ;  49) T AND A CDS MRH , Pack Number CDS982622L ;  50) CAROTID , Pack Number CDS982638J ;  51) NASAL CDS , Pack Number CDS982655C ;  52) NASAL CDS , Pack Number CDS982655D ;  53) NASAL CDS , Pack Number CDS982655F ;  54) NECK THYROID, Pack Number CDS982692M ;  55) NECK THYROID, Pack Number CDS982692N ;  56) NECK THYROID, Pack Number CDS982692O ;  57) TYMPANOPLASTY , Pack Number CDS982720N ;  58) TYMPANOPLASTY , Pack Number CDS982720P ;  59) TYMPANOPLASTY , Pack Number CDS982720Q ;  60) TYMPANOPLASTY , Pack Number CDS982720R ;  61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;  62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;  63) SINUS CDS-1 , Pack Number CDS982901F ;  64) MIDDLE EAR CDS, Pack Number CDS982938J ;  65) MIDDLE EAR CDS, Pack Number CDS982938K ;  66) MIDDLE EAR CDS, Pack Number CDS982938L ;  67) MIDDLE EAR CDS, Pack Number CDS982938O ;  68) SMR/RHINO CDS , Pack Number CDS982939L ;  69) SMR/RHINO CDS , Pack Number CDS982939M ;  70) SMR/RHINO CDS , Pack Number CDS982939N ;  71) SMR/RHINO CDS , Pack Number CDS982939Q ;  72) SMR/RHINO CDS , Pack Number CDS982939R ;  73) SMR/RHINO CDS , Pack Number CDS982939S ;  74) T&A CDS , Pack Number CDS982944J ;  75) T&A CDS , Pack Number CDS982944K ;  76) MINOR EAR , Pack Number CDS982989K ;  77) MINOR EAR , Pack Number CDS982989L ;  78) MINOR EAR , Pack Number CDS982989M ;  79) MINOR EAR , Pack Number CDS982989N ;  80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;  81) ENT CDS , Pack Number CDS983035J ;  82) ENT CDS , Pack Number CDS983035L ;  83) ENT CDS , Pack Number CDS983035M ;  84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;  85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;  86) HEAD & NECK CDS , Pack Number CDS983126B ;  87) HEAD & NECK CDS , Pack Number CDS983126C ;  88) CAROTID CDS- (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-3002-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NECK, Pack Number CDS980809K ;  23) EENT-HEAD AND NECK, Pack Number CDS980809L ;  24) EENT-HEAD AND NECK, Pack Number CDS980809M ;  25) FESS PROCEDURE, Pack Number CDS981185B ;  26) CDS981571P, Pack Number CDS981571P ;  27) SINUS CDS-LF, Pack Number CDS981692J ;  28) EAR CDS , Pack Number CDS981985F ;  29) MAJOR EAR , Pack Number CDS982016Q ;  30) MAJOR EAR , Pack Number CDS982016R ;  31) MAJOR EAR , Pack Number CDS982016S ;  32) MAJOR EAR , Pack Number CDS982016T ;  33) SINUS , Pack Number CDS982020O ;  34) SINUS , Pack Number CDS982020P ;  35) SINUS , Pack Number CDS982020R ;  36) NASAL/SEPTAL, Pack Number CDS982049M;  37) NASAL/SEPTAL, Pack Number CDS982049O;  38) T&A CDS-LF, Pack Number CDS982091I ;  39) EAR-EENT CDS, Pack Number CDS982307F ;  40) EAR-EENT CDS, Pack Number CDS982307G ;  41) EAR-EENT CDS, Pack Number CDS982307J ;  42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;  43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;  44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;  45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;  46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;  47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;  48) EAR CDS-LF, Pack Number CDS982612B ;  49) T AND A CDS MRH , Pack Number CDS982622L ;  50) CAROTID , Pack Number CDS982638J ;  51) NASAL CDS , Pack Number CDS982655C ;  52) NASAL CDS , Pack Number CDS982655D ;  53) NASAL CDS , Pack Number CDS982655F ;  54) NECK THYROID, Pack Number CDS982692M ;  55) NECK THYROID, Pack Number CDS982692N ;  56) NECK THYROID, Pack Number CDS982692O ;  57) TYMPANOPLASTY , Pack Number CDS982720N ;  58) TYMPANOPLASTY , Pack Number CDS982720P ;  59) TYMPANOPLASTY , Pack Number CDS982720Q ;  60) TYMPANOPLASTY , Pack Number CDS982720R ;  61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;  62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;  63) SINUS CDS-1 , Pack Number CDS982901F ;  64) MIDDLE EAR CDS, Pack Number CDS982938J ;  65) MIDDLE EAR CDS, Pack Number CDS982938K ;  66) MIDDLE EAR CDS, Pack Number CDS982938L ;  67) MIDDLE EAR CDS, Pack Number CDS982938O ;  68) SMR/RHINO CDS , Pack Number CDS982939L ;  69) SMR/RHINO CDS , Pack Number CDS982939M ;  70) SMR/RHINO CDS , Pack Number CDS982939N ;  71) SMR/RHINO CDS , Pack Number CDS982939Q ;  72) SMR/RHINO CDS , Pack Number CDS982939R ;  73) SMR/RHINO CDS , Pack Number CDS982939S ;  74) T&A CDS , Pack Number CDS982944J ;  75) T&A CDS , Pack Number CDS982944K ;  76) MINOR EAR , Pack Number CDS982989K ;  77) MINOR EAR , Pack Number CDS982989L ;  78) MINOR EAR , Pack Number CDS982989M ;  79) MINOR EAR , Pack Number CDS982989N ;  80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;  81) ENT CDS , Pack Number CDS983035J ;  82) ENT CDS , Pack Number CDS983035L ;  83) ENT CDS , Pack Number CDS983035M ;  84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;  85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;  86) HEAD & NECK CDS , Pack Number CDS983126B ;  87) HEAD & NECK CDS , Pack Number CDS983126C ;  88) CAROTID CDS-",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3002-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3002-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NECK, Pack Number CDS980809K ;  23) EENT-HEAD AND NECK, Pack Number CDS980809L ;  24) EENT-HEAD AND NECK, Pack Number CDS980809M ;  25) FESS PROCEDURE, Pack Number CDS981185B ;  26) CDS981571P, Pack Number CDS981571P ;  27) SINUS CDS-LF, Pack Number CDS981692J ;  28) EAR CDS , Pack Number CDS981985F ;  29) MAJOR EAR , Pack Number CDS982016Q ;  30) MAJOR EAR , Pack Number CDS982016R ;  31) MAJOR EAR , Pack Number CDS982016S ;  32) MAJOR EAR , Pack Number CDS982016T ;  33) SINUS , Pack Number CDS982020O ;  34) SINUS , Pack Number CDS982020P ;  35) SINUS , Pack Number CDS982020R ;  36) NASAL/SEPTAL, Pack Number CDS982049M;  37) NASAL/SEPTAL, Pack Number CDS982049O;  38) T&A CDS-LF, Pack Number CDS982091I ;  39) EAR-EENT CDS, Pack Number CDS982307F ;  40) EAR-EENT CDS, Pack Number CDS982307G ;  41) EAR-EENT CDS, Pack Number CDS982307J ;  42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;  43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;  44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;  45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;  46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;  47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;  48) EAR CDS-LF, Pack Number CDS982612B ;  49) T AND A CDS MRH , Pack Number CDS982622L ;  50) CAROTID , Pack Number CDS982638J ;  51) NASAL CDS , Pack Number CDS982655C ;  52) NASAL CDS , Pack Number CDS982655D ;  53) NASAL CDS , Pack Number CDS982655F ;  54) NECK THYROID, Pack Number CDS982692M ;  55) NECK THYROID, Pack Number CDS982692N ;  56) NECK THYROID, Pack Number CDS982692O ;  57) TYMPANOPLASTY , Pack Number CDS982720N ;  58) TYMPANOPLASTY , Pack Number CDS982720P ;  59) TYMPANOPLASTY , Pack Number CDS982720Q ;  60) TYMPANOPLASTY , Pack Number CDS982720R ;  61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;  62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;  63) SINUS CDS-1 , Pack Number CDS982901F ;  64) MIDDLE EAR CDS, Pack Number CDS982938J ;  65) MIDDLE EAR CDS, Pack Number CDS982938K ;  66) MIDDLE EAR CDS, Pack Number CDS982938L ;  67) MIDDLE EAR CDS, Pack Number CDS982938O ;  68) SMR/RHINO CDS , Pack Number CDS982939L ;  69) SMR/RHINO CDS , Pack Number CDS982939M ;  70) SMR/RHINO CDS , Pack Number CDS982939N ;  71) SMR/RHINO CDS , Pack Number CDS982939Q ;  72) SMR/RHINO CDS , Pack Number CDS982939R ;  73) SMR/RHINO CDS , Pack Number CDS982939S ;  74) T&A CDS , Pack Number CDS982944J ;  75) T&A CDS , Pack Number CDS982944K ;  76) MINOR EAR , Pack Number CDS982989K ;  77) MINOR EAR , Pack Number CDS982989L ;  78) MINOR EAR , Pack Number CDS982989M ;  79) MINOR EAR , Pack Number CDS982989N ;  80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;  81) ENT CDS , Pack Number CDS983035J ;  82) ENT CDS , Pack Number CDS983035L ;  83) ENT CDS , Pack Number CDS983035M ;  84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;  85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;  86) HEAD & NECK CDS , Pack Number CDS983126B ;  87) HEAD & NECK CDS , Pack Number CDS983126C ;  88) CAROTID CDS-",
      "text": "The FDA logged enforcement record Z-3002-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) HEAD & NECK TRAY, Pack Number AM310B ;  2) HEAD & NECK CDS , Pack Number CDS780161K ;  3) HEAD & NECK CDS , Pack Number CDS780161L ;  4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ;  5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ;  6) CAROTID CDS-LF, Pack Number CDS840056N ;  7) CAROTID-LF, Pack Number CDS860039J ;  8) T & A PROCEDURE-LF, Pack Number CDS860047X ;  9) THORACOTOMY CDS , Pack Number CDS920065R ;  10) EAR CDS , Pack Number CDS980089L ;  11) EAR CDS , Pack Number CDS980089M ;  12) EAR CDS , Pack Number CDS980089N ;  13) EAR CDS , Pack Number CDS980089O ;  14) ENDOSCOPY , Pack Number CDS980201R ;  15) TYMPANOPLASTY , Pack Number CDS980203R ;  16) TYMPANOPLASTY , Pack Number CDS980203S ;  17) TYMPANO CDS , Pack Number CDS980374M ;  18) TYMPANO CDS , Pack Number CDS980374O ;  19) TYMPANO CDS , Pack Number CDS980374P ;  20) THORACOTOMY CDS , Pack Number CDS980446T ;  21) SINUS CDS , Pack Number CDS980579D ;  22) EENT-HEAD AND NECK, Pack Number CDS980809K ;  23) EENT-HEAD AND NECK, Pack Number CDS980809L ;  24) EENT-HEAD AND NECK, Pack Number CDS980809M ;  25) FESS PROCEDURE, Pack Number CDS981185B ;  26) CDS981571P, Pack Number CDS981571P ;  27) SINUS CDS-LF, Pack Number CDS981692J ;  28) EAR CDS , Pack Number CDS981985F ;  29) MAJOR EAR , Pack Number CDS982016Q ;  30) MAJOR EAR , Pack Number CDS982016R ;  31) MAJOR EAR , Pack Number CDS982016S ;  32) MAJOR EAR , Pack Number CDS982016T ;  33) SINUS , Pack Number CDS982020O ;  34) SINUS , Pack Number CDS982020P ;  35) SINUS , Pack Number CDS982020R ;  36) NASAL/SEPTAL, Pack Number CDS982049M;  37) NASAL/SEPTAL, Pack Number CDS982049O;  38) T&A CDS-LF, Pack Number CDS982091I ;  39) EAR-EENT CDS, Pack Number CDS982307F ;  40) EAR-EENT CDS, Pack Number CDS982307G ;  41) EAR-EENT CDS, Pack Number CDS982307J ;  42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ;  43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ;  44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ;  45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ;  46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ;  47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ;  48) EAR CDS-LF, Pack Number CDS982612B ;  49) T AND A CDS MRH , Pack Number CDS982622L ;  50) CAROTID , Pack Number CDS982638J ;  51) NASAL CDS , Pack Number CDS982655C ;  52) NASAL CDS , Pack Number CDS982655D ;  53) NASAL CDS , Pack Number CDS982655F ;  54) NECK THYROID, Pack Number CDS982692M ;  55) NECK THYROID, Pack Number CDS982692N ;  56) NECK THYROID, Pack Number CDS982692O ;  57) TYMPANOPLASTY , Pack Number CDS982720N ;  58) TYMPANOPLASTY , Pack Number CDS982720P ;  59) TYMPANOPLASTY , Pack Number CDS982720Q ;  60) TYMPANOPLASTY , Pack Number CDS982720R ;  61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ;  62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ;  63) SINUS CDS-1 , Pack Number CDS982901F ;  64) MIDDLE EAR CDS, Pack Number CDS982938J ;  65) MIDDLE EAR CDS, Pack Number CDS982938K ;  66) MIDDLE EAR CDS, Pack Number CDS982938L ;  67) MIDDLE EAR CDS, Pack Number CDS982938O ;  68) SMR/RHINO CDS , Pack Number CDS982939L ;  69) SMR/RHINO CDS , Pack Number CDS982939M ;  70) SMR/RHINO CDS , Pack Number CDS982939N ;  71) SMR/RHINO CDS , Pack Number CDS982939Q ;  72) SMR/RHINO CDS , Pack Number CDS982939R ;  73) SMR/RHINO CDS , Pack Number CDS982939S ;  74) T&A CDS , Pack Number CDS982944J ;  75) T&A CDS , Pack Number CDS982944K ;  76) MINOR EAR , Pack Number CDS982989K ;  77) MINOR EAR , Pack Number CDS982989L ;  78) MINOR EAR , Pack Number CDS982989M ;  79) MINOR EAR , Pack Number CDS982989N ;  80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ;  81) ENT CDS , Pack Number CDS983035J ;  82) ENT CDS , Pack Number CDS983035L ;  83) ENT CDS , Pack Number CDS983035M ;  84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ;  85) CHP TYMPMASTOID CDS, Pack Number CDS983088J;  86) HEAD & NECK CDS , Pack Number CDS983126B ;  87) HEAD & NECK CDS , Pack Number CDS983126C ;  88) CAROTID CDS- — 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: AM310B , Lot Number 20BBX607 ;  AM310B , Lot Number 20FBO876 ;  AM310B , Lot Number 20HBG464 ;  AM310B , Lot Number 20HBT869 ;  AM310B , Lot Number 20JBW307 ;  AM310B , Lot Number 20XBG776 ;  CDS780161K , Lot Number 19ABJ175 ;  CDS780161K , Lot Number 19CBC247 ;  CDS780161K , Lot Number 19DBJ688 ;  CDS780161L , Lot Number 21FBM662 ;  CDS780161L , Lot Number 21JBO079 ;  CDS780161L , Lot Number 21KBU620 ;  CDS780161L , Lot Number 22DBN197 ;  CDS780161L , Lot Number 22EBE676 ;  CDS780161L , Lot Number 22GBA238 ;  CDS780161L , Lot Number 19FBZ495 ;  CDS780161L , Lot Number 22HBH827 ;  CDS780161L , Lot Number 22JBA466 ;  CDS780161L , Lot Number 22JBR842 ;  CDS780161L , Lot Number 19IBA021 ;  CDS780161L , Lot Number 22LBG736 ;  CDS780161L , Lot Number 23ABC482 ;  CDS780161L , Lot Number 19KBD885 ;  CDS780161L , Lot Number 23BBK773 ;  CDS780161L , Lot Number 23DBH567 ;  CDS780161L , Lot Number 20BBA048 ;  CDS780161L , Lot Number 23EBW865 ;  CDS780161L , Lot Number 23FBR465 ;  CDS780161L , Lot Number 20CBF643 ;  CDS780161L , Lot Number 23HBF094 ;  CDS780161L , Lot Number 20DBQ527 ;  CDS780161L , Lot Number 20EBT660 ;  CDS780161L , Lot Number 23JBG854 ;  CDS780161L , Lot Number 23KBG199 ;  CDS780161L , Lot Number 20GBQ310 ;  CDS780161L , Lot Number 20HBW040 ;  CDS780161L , Lot Number 20KBQ319 ;  CDS780161L , Lot Number 20LBP102 ;  CDS780161L , Lot Number 20LBQ550 ;  CDS780161L , Lot Number 21CBI795 ;  CDS780161L , Lot Number 21DBA543 ;  CDS780161L , Lot Number 21EBA173 ;  CDS780170R , Lot Number 21HBH210 ;  CDS780170R , Lot Number 19ABX183 ;  CDS780170R , Lot Number 19CBG446 ;  CDS780170R , Lot Number 19DBV563 ;  CDS780170R , Lot Number 19GBW741 ;  CDS780170R , Lot Number 19IBQ678 ;  CDS780170R , Lot Number 20BBE129 ;  CDS780170R , Lot Number 20HBH841 ;  CDS780170R , Lot Number 20JBY348 ;  CDS780170R , Lot Number 20KBE437 ;  CDS780170R , Lot Number 21BBN563 ;  CDS780170R , Lot Number 21EBO719 ;  CDS780170S , Lot Number 21LBU027 ;  CDS780170S , Lot Number 22ABC196 ;  CDS780170S , Lot Number 22CBT534 ;  CDS780170S , Lot Number 22DBB138 ;  CDS780170S , Lot Number 22FBY456 ;  CDS780170S , Lot Number 22LMJ227 ;  CDS780170S , Lot Number 23AMB457 ;  CDS780170S , Lot Number 23AMG031 ;  CDS780170S , Lot Number 23BMG081 ;  CDS840056N , Lot Number 19ABS578 ;  CDS840056N , Lot Number 19CBF638 ;  CDS840056N , Lot Number 19DBQ238 ;  CDS840056N , Lot Number 19FBT067 ;  CDS840056N , Lot Number 19JBJ675 ;  CDS860039J , Lot Number 21GBL272 ;  CDS860039J , Lot Number 20FBR859 ;  CDS860039J , Lot Number 20HBH825 ;  CDS860039J , Lot Number 20JBI204 ;  CDS860039J , Lot Number 20KBJ538 ;  CDS860039J , Lot Number 20LBV021 ;  CDS860039J , Lot Number 21CBO329 ;  CDS860039J , Lot Number 21EBA033 ;  CDS860039J , Lot Number 21EBO476 ;  CDS860047X , Lot Number 22KBF748 ;  CDS860047X , Lot Number 23ABC310 ;  CDS860047X , Lot Number 23BBN857 ;  CDS860047X , Lot Number 23CBM719 ;  CDS860047X , Lot Number 23CBR360 ;  CDS860047X , Lot Number 23DBP426 ;  CDS860047X , Lot Number 23EBK702 ;  CDS860047X , Lot Number 23FBE714 ;  CDS860047X , Lot Number 23GBU901 ;  CDS860047X , Lot Number 23HBU599 ;  CDS860047X , Lot Number 23IBO885 ;  CDS920065R , Lot Number 22JLB054 ;  CDS980089L , Lot Number 19BBE268 ;  CDS980089L , Lot Number 19CBL613 ;  CDS980089L , Lot Number 19FBL680 ;  CDS980089L , Lot Number 19TBC919 ;  CDS980089L , Lot Number 19JBK959 ;  CDS980089M , Lot Number 21FBJ093 ;  CDS980089M , Lot Number 21FBJ094 ;  CDS980089M , Lot Number 21FBJ095 ;  CDS980089M , Lot Number 21FBJ096 ;  CDS980089M , Lot Number 21FBJ097 ;  CDS980089M , Lot Number 21FBR314 ;  CDS980089M , Lot Number 21HBG999 ;  CDS980089M , Lot Number 21JBM584 ;  CDS980089M , Lot Number 19KBH835 ;  CDS980089M , Lot Number 20HBU008 ;  CDS980089M , Lot Number 20LBI140 ;  CDS980089M , Lot Number 21BBJ367 ;  CDS980089N , Lot Number 22ABD323 ;  CDS980089N , Lot Number 22ABD324 ;  CDS980089N , Lot Number 22KBM192 ;  CDS980089O , Lot Number 23CBW365 ;  CDS980089O , Lot Number 23EBE453 ;  CDS980089O , Lot Number 23GBB537 ;  CDS980089O , Lot Number 23JBN802 ;  CDS980089O , Lot Number 23LBJ396 ;  CDS980201R , Lot Number 22CBB940 ;  CDS980201R , Lot Number 22OBA201 ;  CDS980203R , Lot Number 19ABW857 ;  CDS980203R , Lot Number 19BBU024 ;  CDS980203R , Lot Number 19DBY788 ;  CDS980203R , Lot Number 19QBA275 ;  CDS980203R , Lot Number 19SBB846 ;  CDS980203R , Lot Number 19LBJ447 ;  CDS980203R , Lot Number 20BBE176 ;  CDS980203R , Lot Number 20DBT319 ;  CDS980203R , Lot Number 20EBA269 ;  CDS980203R , Lot Number 20HBI823 ;  CDS980203R , Lot Number 20IBQ932 ;  CDS980203R , Lot Number 20KBF449 ;  CDS980203R , Lot Number 21ABI747 ;  CDS980203S , Lot Number 21GBS679 ;  CDS980203S , Lot Number 21IBV658 ;  CDS980203S , Lot Number 21KBI373 ;  CDS980203S , Lot Number 21KBK367 ;  CDS980203S , Lot Number 21LBJ704 ;  CDS980203S , Lot Number 22ABF195 ;  CDS980203S , Lot Number 22FBG171 ;  CDS980203S , Lot Number 22HBO399 ;  CDS980203S , Lot Number 22HBS783 ;  CDS980203S , Lot Number 22KBS200 ;  CDS980203S , Lot Number 22LBH807 ;  CDS980203S , Lot Number 22LBH959 ;  CDS980203S , Lot Number 23ABR111 ;  CDS980203S , Lot Number 23DBT154 ;  CDS980203S , Lot Number 23HBT797 ;  CDS980203S , Lot Number 23JBM122 ;  CDS980203S , Lot Number 23LBC884 ;  CDS980203S , Lot Number 21CBW683 ;  CDS980374M , Lot Number 19DBV282 ;  CDS980374M , Lot Number 19EBW414 ;  CDS980374M , Lot Number 19GBF774 ;  CDS980374M , Lot Number 19IBB514 ;  CDS980374M , Lot Number 19LBE165 ;  CDS980374M , Lot Number 20DBH025 ;  CDS980374M , Lot Number 20FBJ581 ;  CDS980374M , Lot Number 20IBD364 ;  CDS980374M , Lot Number 20JBM273 ;  CDS980374M , Lot Number 20KBL921 ;  CDS980374M , Lot Number 21ABG498 ;  CDS980374M , Lot Number 21CBF887 ;  CDS980374O , Lot Number 21IBA010 ;  CDS980374O , Lot Number 21IBT673 ;  CDS980374O , Lot Number 22ABB423 ;  CDS980374O , Lot Number 22OBM366 ;  CDS980374O , Lot Number 22EBU213 ;  CDS980374O , Lot Number 22GBE098 ;  CDS980374O , Lot Number 22GBX430 ;  CDS980374O , Lot Number 22JBN229 ;  CDS980374O , Lot Number 22KBT771 ;  CDS980374O , Lot Number 22LBM391 ;  CDS980374O , Lot Number 23BBG819 ;  CDS980374O , Lot Number 23CBT151 ;  CDS980374P , Lot Number 23FBG020 ;  CDS980374P , Lot Number 23FBV450 ;  CDS980374P , Lot Number 23HBI049 ;  CDS980374P , Lot Number 23IBQ190 ;  CDS980374P , Lot Number 23KBB054 ;  CDS980374P , Lot Number 23KBB055 ;  CDS980374P , Lot Number 23KBB070 ;  CDS980446T , Lot Number 21FBP535 ;  CDS980446T , Lot Number 21FBT733 ;  CDS980446T , Lot Number 21IBR112 ;  CDS980446T , Lot Number 20GBJ881 ;  CDS980446T , Lot Number 20GBW080 ;  CDS980446T , Lot Number 20IBG082 ;  CDS980446T , Lot Number 20LBS189 ;  CDS980446T , Lot Number 21EBE589 ;  CDS980579D , Lot Number 21FBN768 ;  CDS980579D , Lot Number 21IBA072 ;  CDS980579D , Lot Number 21JBC146 ;  CDS980579D , Lot Number 22ABD373 ;  CDS980579D , Lot Number 22BBU367 ;  CDS980579D , Lot Number 19BBJ400 ;  CDS980579D , Lot Number 22DBK641 ;  CDS980579D , Lot Number 19DBE477 ;  CDS980579D , Lot Number 19EBC589 ;  CDS980579D , Lot Number 22FBN678 ;  CDS980579D , Lot Number 19FBO184 ;  CDS980579D , Lot Number 22HBF976 ;  CDS980579D , Lot Number 22HBL188 ;  CDS980579D , Lot Number 19HBY828 ;  CDS980579D , Lot Number 19IBW711 ;  CDS980579D , Lot Number 22LBE888 ;  CDS980579D , Lot Number 23ABD648 ;  CDS980579D , Lot Number 23ABP476 ;  CDS980579D , Lot Number 19LBK646 ;  CDS980579D , Lot Number 23DBD581 ;  CDS980579D , Lot Number 23DBO915 ;  CDS980579D , Lot Number 20BBA370 ;  CDS980579D , Lot Number 23GBK604 ;  CDS980579D , Lot Number 20DBB743 ;  CDS980579D , Lot Number 23JBF547 ;  CDS980579D , Lot Number 20FBR891 ;  CDS980579D , Lot Number 20HBU165 ;  CDS980579D , Lot Number 23LBM852 ;  CDS980579D , Lot Number 24ABJ712 ;  CDS980579D , Lot Number 20JBG228 ;  CDS980579D , Lot Number 20LBG157 ;  CDS980579D , Lot Number 21ABL742 ;  CDS980579D , Lot Number 21EBI490 ;  CDS980579D , Lot Number 21FBB075 ;  CDS980809K , Lot Number 19BBK881 ;  CDS980809K , Lot Number 19CBA199 ;  CDS980809K , Lot Number 19CBV529 ;  CDS980809K , Lot Number 19HBD987 ;  CDS980809L , Lot Number 20CBP755 ;  CDS980809L , Lot Number 20DBT299 ;  CDS980809L , Lot Number 20EBF598 ;  CDS980809L , Lot Number 20FBU281 ;  CDS980809L , Lot Number 21CBQ757 ;  CDS980809M , Lot Number 22CBK304 ;  CDS980809M , Lot Number 22OBE744 ;  CDS980809M , Lot Number 22EBG583 ;  CDS980809M , Lot Number 22EBI113 ;  CDS980809M , Lot Number 22JBP033 ;  CDS980809M , Lot Number 23BBK767 ;  CDS980809M , Lot Number 23DBI050 ;  CDS980809M , Lot Number 23FBP394 ;  CDS981185B , Lot Number 19CDB151 ;  CDS981185B , Lot Number 19DDD096 ;  CDS981185B , Lot Number 19FDA612 ;  CDS981185B , Lot Number 19IDA540 ;  CDS981185B , Lot Number 19LDB150 ;  CDS981185B , Lot Number 20BDA647 ;  CDS981185B , Lot Number 20DDB481 ;  CDS981185B , Lot Number 20IDA733 ;  CDS981185B , Lot Number 20LDA459 ;  CDS981185B , Lot Number 21HDB855 ;  CDS981185B , Lot Number 21IDA882 ;  CDS981185B , Lot Number 21JDB377 ;  CDS981185B , Lot Number 22CDC141 ;  CDS981185B , Lot Number 22EDB625 ;  CDS981185B , Lot Number 23ADB195 ;  CDS981185B , Lot Number 23FDA168 ;  CDS981185B , Lot Number 23GDA870 ;  CDS981185B , Lot Number 23LDB380 ;  CDS981185B , Lot Number 24BDB518 ;  CDS981571P , Lot Number 20IBF435 ;  CDS981571P , Lot Number 20JBD456 ;  CDS981571P , Lot Number 20KBY135 ;  CDS981571P , Lot Number 21ABG837 ;  CDS981692J , Lot Number 21EME021 ;  CDS981692J , Lot Number 21FMB792 ;  CDS981692J , Lot Number 21FMD781 ;  CDS981692J , Lot Number 21GMC528 ;  CDS981692J , Lot Number 21HMF136 ;  CDS981692J , Lot Number 21KMA503 ;  CDS981692J , Lot Number 22AMA586 ;  CDS981692J , Lot Number 22EMB645 ;  CDS981692J , Lot Number 22GMB473 ;  CDS981692J , Lot Number 22GMH942 ;  CDS981692J , Lot Number 22IMD591 ;  CDS981692J , Lot Number 22KMG745 ;  CDS981692J , Lot Number 22LME628 ;  CDS981692J , Lot Number 23CME129 ;  CDS981692J , Lot Number 19CKB351 ;  CDS981692J , Lot Number 19EKA839 ;  CDS981692J , Lot Number 19IKA266 ;  CDS981692J , Lot Number 19JKC199 ;  CDS981692J , Lot Number 19LKB014 ;  CDS981692J , Lot Number 20BKA891 ;  CDS981692J , Lot Number 20GKB237 ;  CDS981692J , Lot Number 20HKB816 ;  CDS981692J , Lot Number 20KKA424 ;  CDS981692J , Lot Number 20LKA784 ;  CDS981985F , Lot Number 21FBL045 ;  CDS981985F , Lot Number 21GBN303 ;  CDS981985F , Lot Number 22EBF907 ;  CDS981985F , Lot Number 22GBG130 ;  CDS981985F , Lot Number 22GBV850 ;  CDS981985F , Lot Number 19GBX996 ;  CDS981985F , Lot Number 22IBS673 ;  CDS981985F , Lot Number 22JBB341 ;  CDS981985F , Lot Number 22LBJ141 ;  CDS981985F , Lot Number 22LBJ307 ;  CDS981985F , Lot Number 19JBX763 ;  CDS981985F , Lot Number 20DBG940 ;  CDS981985F , Lot Number 20EBI924 ;  CDS981985F , Lot Number 23LBE996 ;  CDS981985F , Lot Number 20KBY217 ;  CDS981985F , Lot Number 20XBC512 ;  CDS981985F , Lot Number 21DBG165 ;  CDS981985F , Lot Number 21DBH201 ;  CDS982016Q , Lot Number 19BBF890 ;  CDS982016Q , Lot Number 19CBF185 ;  CDS982016Q , Lot Number 19DBA660 ;  CDS982016Q , Lot Number 19PBB975 ;  CDS982016R , Lot Number 19GBI419 ;  CDS982016R , Lot Number 19HBN034 ; 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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-3002-2024&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-3002-2024&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-3002-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3002-2024 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": {
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        "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-3002-2024&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-3002-2024&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-3002-2024/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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        "adjudged": false,
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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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            "Field": "Reason",
            "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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 CDS982939Q , Lot Number 21KBE082 ;  CDS982939Q , Lot Number 21LBN507 ;  CDS982939Q , Lot Number 22ABZ580 ;  CDS982939Q , Lot Number 22DBO694 ;  CDS982939Q , Lot Number 22EBM378 ;  CDS982939Q , Lot Number 22GBA670 ;  CDS982939Q , Lot Number 20FBJ574 ;  CDS982939Q , Lot Number 20GBG628 ;  CDS982939Q , Lot Number 20IBQ237 ;  CDS982939Q , Lot Number 20LBW859 ;  CDS982939Q , Lot Number 21ABH886 ;  CDS982939Q , Lot Number 21BBE974 ;  CDS982939Q , Lot Number 21DBA582 ;  CDS982939R , Lot Number 23ABE766 ;  CDS982939R , Lot Number 23CBC517 ;  CDS982939R , Lot Number 23CBV079 ;  CDS982939R , Lot Number 23DBD624 ;  CDS982939R , Lot Number 23EBU368 ;  CDS982939R , Lot Number 23FBF588 ;  CDS982939S , Lot Number 23GBV710 ;  CDS982939S , Lot Number 23IBQ669 ;  CDS982939S , Lot Number 23LBV744 ;  CDS982944J , Lot Number 21GBJ340 ;  CDS982944J , Lot Number 21HBF507 ;  CDS982944J , Lot Number 21IBC223 ;  CDS982944J , Lot Number 21JBE528 ;  CDS982944J , Lot Number 21LBN405 ;  CDS982944J , Lot Number 22ABO838 ; 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 CDS982989L , Lot Number 20EBG427 ;  CDS982989L , Lot Number 20GBH770 ;  CDS982989L , Lot Number 21CBI670 ;  CDS982989L , Lot Number 21DBL226 ;  CDS982989M , Lot Number 21GBR909 ;  CDS982989M , Lot Number 21IBO700 ;  CDS982989M , Lot Number 21IBX702 ;  CDS982989N , Lot Number 22ABE667 ;  CDS982989N , Lot Number 22ABE668 ;  CDS982989N , Lot Number 22CBW335 ;  CDS982989N , Lot Number 22CBW338 ;  CDS982989N , Lot Number 22GBS175 ;  CDS982989N , Lot Number 22GBS176 ;  CDS983010G , Lot Number 19GBL162 ;  CDS983010G , Lot Number 19VBC477 ;  CDS983010G , Lot Number 19KBD919 ;  CDS983010G , Lot Number 19KBP655 ;  CDS983010G , Lot Number 19LBL932 ;  CDS983010G , Lot Number 20ABN334 ;  CDS983010G , Lot Number 20DBB524 ;  CDS983010G , Lot Number 20EBG426 ;  CDS983010G , Lot Number 20EBP302 ;  CDS983010G , Lot Number 20EBU296 ;  CDS983035J , Lot Number 19BBH130 ;  CDS983035J , Lot Number 19CBH448 ;  CDS983035J , Lot Number 19CBO440 ;  CDS983035J , Lot Number 19EBI214 ;  CDS983035J , Lot Number 19EBO661 ;  CDS983035L , Lot Number 20JBO062 ;  CDS983035L , Lot Number 20XBC462 ;  CDS983035M , Lot Number 21FBL911 ;  CDS983035M , Lot Number 21GBI150 ;  CDS983035M , Lot Number 21HBT591 ;  CDS983035M , Lot Number 21IBA140 ;  CDS983035M , Lot Number 21IBJ335 ;  CDS983035M , Lot Number 21KBO012 ;  CDS983035M , Lot Number 22OBJ886 ;  CDS983035M , Lot Number 23EBR969 ;  CDS983035M , Lot Number 23FBL637 ;  CDS983035M , Lot Number 23GBN790 ;  CDS983035M , Lot Number 23JBA939 ;  CDS983035M , Lot Number 23KBP630 ;  CDS983035M , Lot Number 23KBX252 ;  CDS983035M , Lot Number 23LBI628 ;  CDS983035M , Lot Number 24ABS144 ;  CDS983087G , Lot Number 21HBH146 ;  CDS983087G , Lot Number 21HBH148 ;  CDS983087G , Lot Number 21VBA210 ;  CDS983088J, Lot Number 23ABM168;  CDS983088J, Lot Number 22LBB288;  CDS983088J, Lot Number 22JBW377;  CDS983088J, Lot Number 22IBR946;  CDS983088J, Lot Number 22HBM640;  CDS983088J, Lot Number 22HBN931;  CDS983088J, Lot Number 22HBM642;  CDS983088J, Lot Number 22DBO479;  CDS983088J, Lot Number 23ABM168;  CDS983088J, Lot Number 22LBB288;  CDS983088J, Lot Number 22JBW377;  CDS983088J, Lot Number 22IBR946;  CDS983088J, Lot Number 22HBM640;  CDS983088J, Lot Number 22HBN931;  CDS983088J, Lot Number 22HBM642;  CDS983088J, Lot Number 22DBO479;  CDS983126B , Lot Number 19ABN016 ;  CDS983126B , Lot Number 19CBK514 ;  CDS983126B , Lot Number 19FBF166 ;  CDS983126B , Lot Number 19SBG848 ;  CDS983126C , Lot Number 19KBC140 ;  CDS983126C , Lot Number 20ABV536 ;  CDS983126C , Lot Number 20HBH783 ;  CDS983126C , Lot Number 20IBI376 ;  CDS983126C , Lot Number 20JBT062 ;  CDS983126C , Lot Number 20LBI163 ;  CDS983126C , Lot Number 21ABV524 ;  CDS983139A , Lot Number 19ABM547 ;  CDS983139A , Lot Number 19CBF260 ;  CDS983139A , Lot Number 19CBK755 ;  CDS983139A , Lot Number 19DBF987 ;  CDS983139A , Lot Number 19FBJ779 ;  CDS983139A , Lot Number 19FBZ756 ;  CDS983139A , Lot Number 19GBX147 ;  CDS983139A , Lot Number 19IBO536 ;  CDS983139A , Lot Number 19JBI350 ;  CDS983139A , Lot Number 19VBF786 ;  CDS983139B , Lot Number 21FBJ082 ;  CDS983139B , Lot Number 21GBE864 ;  CDS983139B , Lot Number 21HBC597 ;  CDS983139B , Lot Number 21LBM269 ;  CDS983139B , Lot Number 22ABL217 ;  CDS983139B , Lot Number 22BBJ850 ;  CDS983139B , Lot Number 22BBV592 ;  CDS983139B , Lot Number 20CBN616 ;  CDS983139B , Lot Number 20DBM218 ;  CDS983139B , Lot Number 20FBD832 ;  CDS983139B , Lot Number 20HBV523 ;  CDS983139B , Lot Number 20IBS611 ;  CDS983139B , Lot Number 20LBW853 ;  CDS983139B , Lot Number 20XBH113 ;  CDS983142C , Lot Number 21FBN817 ;  CDS983142C , Lot Number 22ABT796 ;  CDS983142C , Lot Number 22ABT797 ;  CDS983142C , Lot Number 22BBA393 ;  CDS983142C , Lot Number 22IBB522 ;  CDS983142C , Lot Number 20DBH141 ;  CDS983142C , Lot Number 20EBJ961 ;  CDS983142C , Lot Number 20IBL516 ;  CDS983178D , Lot Number 21GBN275 ;  CDS983178D , Lot Number 21IBT664 ;  CDS983178D , Lot Number 21JBO038 ;  CDS983178D , Lot Number 21LBG253 ;  CDS983178D , Lot Number 22BBA124 ;  CDS983178D , Lot Number 19ABF948 ;  CDS983178D , Lot Number 19BBD305 ;  CDS983178D , Lot Number 22CBL563 ;  CDS983178D , Lot Number 19CBW884 ;  CDS983178D , Lot Number 22EBC371 ;  CDS983178D , Lot Number 22EBD213 ;  CDS983178D , Lot Number 19EBZ746 ;  CDS983178D , Lot Number 19GBB101 ;  CDS983178D , Lot Number 19IBC345 ;  CDS983178D , Lot Number 19IBC633 ;  CDS983178D , Lot Number 19JBL299 ;  CDS983178D , Lot Number 19KBZ024 ;  CDS983178D , Lot Number 20ABH048 ;  CDS983178D , Lot Number 20BBQ317 ;  CDS983178D , Lot Number 20CBP836 ;  CDS983178D , Lot Number 20EBG186 ;  CDS983178D , Lot Number 20GBD065 ;  CDS983178D , Lot Number 20IBN724 ;  CDS983178D , Lot Number 20JBX943 ;  CDS983178D , Lot Number 21ABO804 ;  CDS983178D , Lot Number 21ABP999 ;  CDS983178D , Lot Number 21DBC491 ;  CDS983178D , Lot Number 21FBC638 ;  CDS983178D , Lot Number 21FBC639 ;  CDS983178F , Lot Number 22GBB109 ;  CDS983178F , Lot Number 22IBC429 ;  CDS983178F , Lot Number 22JBC334 ;  CDS983178G , Lot Number 22KBO917 ;  CDS983178I , Lot Number 23ABD213 ;  CDS983178I , Lot Number 23ABT114 ;  CDS983178I , Lot Number 23BBU908 ;  CDS983178I , Lot Number 23CBG894 ;  CDS983178I , Lot Number 23DBE126 ;  CDS983178I , Lot Number 23GBI251 ;  CDS983178I , Lot Number 23GBI927 ;  CDS983178I , Lot Number 23HBO013 ;  CDS983178I , Lot Number 23JBQ340 ;  CDS983178I , Lot Number 23KBF403 ;  CDS983178I , Lot Number 23LBI653 ;  CDS983178I , Lot Number 24BBC965 ;  CDS983181F , Lot Number 22FBX036 ;  CDS983181F , Lot Number 22IBJ058 ;  CDS983181F , Lot Number 22IBQ523 ;  CDS983181F , Lot Number 22LBT176 ;  CDS983181F , Lot Number 23ABT115 ;  CDS983181F , Lot Number 23BBJ894 ;  CDS983181F , Lot Number 23EBJ325 ;  CDS983181F , Lot Number 23FBH145 ;  CDS983181F , Lot Number 23GBO776 ;  CDS983181F , Lot Number 23GBP590 ;  CDS983181F , Lot Number 23IBC608 ;  CDS983181F , Lot Number 23KBE427 ;  CDS983181F , Lot Number 23KBF412 ;  CDS983184I , Lot Number 22GBV926 ;  CDS983184I , Lot Number 22IBJ687 ;  CDS983184I , Lot Number 22IBO795 ;  CDS983184I , Lot Number 22LBB795 ;  CDS983184I , Lot Number 22LBP673 ;  CDS983184I , Lot Number 23BBH106 ;  CDS983184I , Lot Number 23BBU916 ;  CDS983184I , Lot Number 23CBT619 ;  CDS983184I , Lot Number 23EBE530 ;  CDS983184I , Lot Number 23FBJ754 ;  CDS983184I , Lot Number 23HBP974 ;  CDS983184I , Lot Number 23HBY087 ;  CDS983184I , Lot Number 23JBF563 ;  CDS983184I , Lot Number 23KBI669 ;  CDS983184I , Lot Number 23KBM394 ;  CDS983184I , Lot Number 23LBD939 ;  CDS983184I , Lot Number 24ABI467 ;  CDS983209I , Lot Number 21GBG958 ;  CDS983209I , Lot Number 21IBV512 ;  CDS983209I , Lot Number 21KBW919 ;  CDS983209I , Lot Number 22ABX999 ;  CDS983209I , Lot Number 22BBA120 ;  CDS983209I , Lot Number 22CBD916 ;  CDS983209I , Lot Number 22EBB414 ;  CDS983209I , Lot Number 22EBD173 ;  CDS983209I , Lot Number 22FBN422 ;  CDS983209I , Lot Number 19FBM137 ;  CDS983209I , Lot Number 19SBE417 ;  CDS983209I , Lot Number 19HBM775 ;  CDS983209I , Lot Number 19JBS127 ;  CDS983209I , Lot Number 19KBZ007 ;  CDS983209I , Lot Number 19LBW572 ;  CDS983209I , Lot Number 20BBN555 ;  CDS983209I , Lot Number 20CBX026 ;  CDS983209I , Lot Number 20DBG926 ;  CDS983209I , Lot Number 20DBN227 ;  CDS983209I , Lot Number 20EBT051 ;  CDS983209I , Lot Number 21DBH496 ;  CDS983209I , Lot Number 21EBQ888 ;  CDS983209J , Lot Number 22JBC280 ;  CDS983209J , Lot Number 23ABO115 ;  CDS983209K , Lot Number 23CBV670 ;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}