{
  "@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-3052-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;  2) ARTHROSCOPY TRAY, Pack Number AM110A ;  3) HIP , Pack Number BM200A ;  4) SHOULDER ARTHROSCOPY, Pack Number BM230A ;  5) KNEE ARTHROSCOPY, Pack Number BM240A ;  6) PODIATRY PACK , Pack Number BM250A ;  7) CRANIOTOMY CDS, Pack Number CDS780025AA;  8) CRANIOTOMY CDS, Pack Number CDS780025AB;  9) CRANIOTOMY CDS, Pack Number CDS780025AC;  10) CRANIOTOMY CDS, Pack Number CDS780025X ;  11) CRANIOTOMY CDS, Pack Number CDS780025Y ;  12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ;  13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ;  14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ;  15) CRANIOTOMY CDS, Pack Number CDS780046O ;  16) CRANI , Pack Number CDS780089V ;  17) CRANI , Pack Number CDS780089W ;  18) CRANI , Pack Number CDS780089X ;  19) CRANIOFACIAL CDS, Pack Number CDS780102K ;  20) CRANIOFACIAL CDS, Pack Number CDS780102L ;  21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ;  22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ;  23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ;  24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ;  25) CRANIOTOMY-LF , Pack Number CDS780111M ;  26) CRANIOTOMY-LF , Pack Number CDS780111N ;  27) CRANIOTOMY-LF , Pack Number CDS780111O ;  28) CRANIOTOMY-LF , Pack Number CDS780111P ;  29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ;  30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ;  31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH;  32) BASIC BACK CDS, Pack Number CDS780147K ;  33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ;  34) LAMINECTOMY CDS , Pack Number CDS780165L ;  35) LAMINECTOMY CDS , Pack Number CDS780165M ;  36) LAMINECTOMY CDS , Pack Number CDS780165N ;  37) LAMINECTOMY CDS , Pack Number CDS780165O ;  38) LAMINECTOMY CDS , Pack Number CDS780165Q ;  39) LAMINECTOMY CDS , Pack Number CDS780165R ;  40) CRANIOTOMY CDS, Pack Number CDS780166Q ;  41) CRANIOTOMY CDS, Pack Number CDS780166R ;  42) CRANIOTOMY CDS, Pack Number CDS780166S ;  43) CRANIOTOMY CDS, Pack Number CDS780166T ;  44) CRANIOTOMY CDS, Pack Number CDS780166U ;  45) CRANIOTOMY CDS, Pack Number CDS780166V ;  46) DR WOLF SPINE CDS , Pack Number CDS780168P ;  47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ;  48) SPINAL FUSION CDS , Pack Number CDS780197N ;  49) SPINAL FUSION PACK, Pack Number CDS780197P ;  50) SPINAL FUSION PACK, Pack Number CDS780197Q ;  51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ;  52) LAMINECTOMY CDS , Pack Number CDS780203J ;  53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ;  54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ;  55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ;  56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ;  57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ;  58) CRANIOTOMY CDS, Pack Number CDS780206O ;  59) CRANIOTOMY CDS, Pack Number CDS780206P ;  60) CRANIOTOMY CDS, Pack Number CDS780206R ;  61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ;  62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ;  63) NEURO-LAMI CDS, Pack Number CDS780208I ;  64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ;  65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ;  66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ;  67) SPINE CDS , Pack Number CDS780228D ;  68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ;  69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ;  70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ;  71) SPINE CDS-LF, Pack Number CDS780236L ;  72) SPINE CDS-LF, Pack Number CDS780236M ;  73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ;  74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ;  75) SPINAL FUSION , Pack Number CDS860017AA;  76) SPINAL FUSION , Pack Number CDS860017AB;  77) SPINAL FUSION , Pack Number CDS860017AC;  78) FUSION CDS, Pack Number CDS860138D ;  79) FUSION CDS, Pack Number CDS860138F ;  80) FUSION CDS, Pack Number CDS860138G ;  81) LUMBAR, Pack Number CDS860170I ;  82) LUMBAR, Pack Number CDS860170J ;  83) LUMBAR, Pack Numbe",
  "description": "FDA recall Z-3052-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;  2) ARTHROSCOPY TRAY, Pack Number AM110A ;  3) HIP , Pack Number BM200A ;  4) SHOULDER ARTHROSCOPY, Pack Number BM230A ;  5) KNEE ARTHROSCOPY, Pack Number BM240A ;  6) PODIATRY PACK , Pack Number BM250A ;  7) CRANIOTOMY CDS, Pack Number CDS780025AA;  8) CRANIOTOMY CDS, Pack Number CDS780025AB;  9) CRANIOTOMY CDS, Pack Number CDS780025AC;  10) CRANIOTOMY CDS, Pack Number CDS780025X ;  11) CRANIOTOMY CDS, Pack Number CDS780025Y ;  12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ;  13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ;  14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ;  15) CRANIOTOMY CDS, Pack Number CDS780046O ;  16) CRANI , Pack Number CDS780089V ;  17) CRANI , Pack Number CDS780089W ;  18) CRANI , Pack Number CDS780089X ;  19) CRANIOFACIAL CDS, Pack Number CDS780102K ;  20) CRANIOFACIAL CDS, Pack Number CDS780102L ;  21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ;  22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ;  23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ;  24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ;  25) CRANIOTOMY-LF , Pack Number CDS780111M ;  26) CRANIOTOMY-LF , Pack Number CDS780111N ;  27) CRANIOTOMY-LF , Pack Number CDS780111O ;  28) CRANIOTOMY-LF , Pack Number CDS780111P ;  29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ;  30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ;  31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH;  32) BASIC BACK CDS, Pack Number CDS780147K ;  33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ;  34) LAMINECTOMY CDS , Pack Number CDS780165L ;  35) LAMINECTOMY CDS , Pack Number CDS780165M ;  36) LAMINECTOMY CDS , Pack Number CDS780165N ;  37) LAMINECTOMY CDS , Pack Number CDS780165O ;  38) LAMINECTOMY CDS , Pack Number CDS780165Q ;  39) LAMINECTOMY CDS , Pack Number CDS780165R ;  40) CRANIOTOMY CDS, Pack Number CDS780166Q ;  41) CRANIOTOMY CDS, Pack Number CDS780166R ;  42) CRANIOTOMY CDS, Pack Number CDS780166S ;  43) CRANIOTOMY CDS, Pack Number CDS780166T ;  44) CRANIOTOMY CDS, Pack Number CDS780166U ;  45) CRANIOTOMY CDS, Pack Number CDS780166V ;  46) DR WOLF SPINE CDS , Pack Number CDS780168P ;  47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ;  48) SPINAL FUSION CDS , Pack Number CDS780197N ;  49) SPINAL FUSION PACK, Pack Number CDS780197P ;  50) SPINAL FUSION PACK, Pack Number CDS780197Q ;  51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ;  52) LAMINECTOMY CDS , Pack Number CDS780203J ;  53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ;  54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ;  55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ;  56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ;  57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ;  58) CRANIOTOMY CDS, Pack Number CDS780206O ;  59) CRANIOTOMY CDS, Pack Number CDS780206P ;  60) CRANIOTOMY CDS, Pack Number CDS780206R ;  61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ;  62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ;  63) NEURO-LAMI CDS, Pack Number CDS780208I ;  64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ;  65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ;  66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ;  67) SPINE CDS , Pack Number CDS780228D ;  68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ;  69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ;  70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ;  71) SPINE CDS-LF, Pack Number CDS780236L ;  72) SPINE CDS-LF, Pack Number CDS780236M ;  73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ;  74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ;  75) SPINAL FUSION , Pack Number CDS860017AA;  76) SPINAL FUSION , Pack Number CDS860017AB;  77) SPINAL FUSION , Pack Number CDS860017AC;  78) FUSION CDS, Pack Number CDS860138D ;  79) FUSION CDS, Pack Number CDS860138F ;  80) FUSION CDS, Pack Number CDS860138G ;  81) LUMBAR, Pack Number CDS860170I ;  82) LUMBAR, Pack Number CDS860170J ;  83) LUMBAR, Pack Numbe (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-3052-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;  2) ARTHROSCOPY TRAY, Pack Number AM110A ;  3) HIP , Pack Number BM200A ;  4) SHOULDER ARTHROSCOPY, Pack Number BM230A ;  5) KNEE ARTHROSCOPY, Pack Number BM240A ;  6) PODIATRY PACK , Pack Number BM250A ;  7) CRANIOTOMY CDS, Pack Number CDS780025AA;  8) CRANIOTOMY CDS, Pack Number CDS780025AB;  9) CRANIOTOMY CDS, Pack Number CDS780025AC;  10) CRANIOTOMY CDS, Pack Number CDS780025X ;  11) CRANIOTOMY CDS, Pack Number CDS780025Y ;  12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ;  13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ;  14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ;  15) CRANIOTOMY CDS, Pack Number CDS780046O ;  16) CRANI , Pack Number CDS780089V ;  17) CRANI , Pack Number CDS780089W ;  18) CRANI , Pack Number CDS780089X ;  19) CRANIOFACIAL CDS, Pack Number CDS780102K ;  20) CRANIOFACIAL CDS, Pack Number CDS780102L ;  21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ;  22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ;  23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ;  24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ;  25) CRANIOTOMY-LF , Pack Number CDS780111M ;  26) CRANIOTOMY-LF , Pack Number CDS780111N ;  27) CRANIOTOMY-LF , Pack Number CDS780111O ;  28) CRANIOTOMY-LF , Pack Number CDS780111P ;  29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ;  30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ;  31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH;  32) BASIC BACK CDS, Pack Number CDS780147K ;  33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ;  34) LAMINECTOMY CDS , Pack Number CDS780165L ;  35) LAMINECTOMY CDS , Pack Number CDS780165M ;  36) LAMINECTOMY CDS , Pack Number CDS780165N ;  37) LAMINECTOMY CDS , Pack Number CDS780165O ;  38) LAMINECTOMY CDS , Pack Number CDS780165Q ;  39) LAMINECTOMY CDS , Pack Number CDS780165R ;  40) CRANIOTOMY CDS, Pack Number CDS780166Q ;  41) CRANIOTOMY CDS, Pack Number CDS780166R ;  42) CRANIOTOMY CDS, Pack Number CDS780166S ;  43) CRANIOTOMY CDS, Pack Number CDS780166T ;  44) CRANIOTOMY CDS, Pack Number CDS780166U ;  45) CRANIOTOMY CDS, Pack Number CDS780166V ;  46) DR WOLF SPINE CDS , Pack Number CDS780168P ;  47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ;  48) SPINAL FUSION CDS , Pack Number CDS780197N ;  49) SPINAL FUSION PACK, Pack Number CDS780197P ;  50) SPINAL FUSION PACK, Pack Number CDS780197Q ;  51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ;  52) LAMINECTOMY CDS , Pack Number CDS780203J ;  53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ;  54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ;  55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ;  56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ;  57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ;  58) CRANIOTOMY CDS, Pack Number CDS780206O ;  59) CRANIOTOMY CDS, Pack Number CDS780206P ;  60) CRANIOTOMY CDS, Pack Number CDS780206R ;  61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ;  62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ;  63) NEURO-LAMI CDS, Pack Number CDS780208I ;  64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ;  65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ;  66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ;  67) SPINE CDS , Pack Number CDS780228D ;  68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ;  69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ;  70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ;  71) SPINE CDS-LF, Pack Number CDS780236L ;  72) SPINE CDS-LF, Pack Number CDS780236M ;  73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ;  74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ;  75) SPINAL FUSION , Pack Number CDS860017AA;  76) SPINAL FUSION , Pack Number CDS860017AB;  77) SPINAL FUSION , Pack Number CDS860017AC;  78) FUSION CDS, Pack Number CDS860138D ;  79) FUSION CDS, Pack Number CDS860138F ;  80) FUSION CDS, Pack Number CDS860138G ;  81) LUMBAR, Pack Number CDS860170I ;  82) LUMBAR, Pack Number CDS860170J ;  83) LUMBAR, Pack Numbe",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3052-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3052-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;  2) ARTHROSCOPY TRAY, Pack Number AM110A ;  3) HIP , Pack Number BM200A ;  4) SHOULDER ARTHROSCOPY, Pack Number BM230A ;  5) KNEE ARTHROSCOPY, Pack Number BM240A ;  6) PODIATRY PACK , Pack Number BM250A ;  7) CRANIOTOMY CDS, Pack Number CDS780025AA;  8) CRANIOTOMY CDS, Pack Number CDS780025AB;  9) CRANIOTOMY CDS, Pack Number CDS780025AC;  10) CRANIOTOMY CDS, Pack Number CDS780025X ;  11) CRANIOTOMY CDS, Pack Number CDS780025Y ;  12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ;  13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ;  14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ;  15) CRANIOTOMY CDS, Pack Number CDS780046O ;  16) CRANI , Pack Number CDS780089V ;  17) CRANI , Pack Number CDS780089W ;  18) CRANI , Pack Number CDS780089X ;  19) CRANIOFACIAL CDS, Pack Number CDS780102K ;  20) CRANIOFACIAL CDS, Pack Number CDS780102L ;  21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ;  22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ;  23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ;  24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ;  25) CRANIOTOMY-LF , Pack Number CDS780111M ;  26) CRANIOTOMY-LF , Pack Number CDS780111N ;  27) CRANIOTOMY-LF , Pack Number CDS780111O ;  28) CRANIOTOMY-LF , Pack Number CDS780111P ;  29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ;  30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ;  31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH;  32) BASIC BACK CDS, Pack Number CDS780147K ;  33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ;  34) LAMINECTOMY CDS , Pack Number CDS780165L ;  35) LAMINECTOMY CDS , Pack Number CDS780165M ;  36) LAMINECTOMY CDS , Pack Number CDS780165N ;  37) LAMINECTOMY CDS , Pack Number CDS780165O ;  38) LAMINECTOMY CDS , Pack Number CDS780165Q ;  39) LAMINECTOMY CDS , Pack Number CDS780165R ;  40) CRANIOTOMY CDS, Pack Number CDS780166Q ;  41) CRANIOTOMY CDS, Pack Number CDS780166R ;  42) CRANIOTOMY CDS, Pack Number CDS780166S ;  43) CRANIOTOMY CDS, Pack Number CDS780166T ;  44) CRANIOTOMY CDS, Pack Number CDS780166U ;  45) CRANIOTOMY CDS, Pack Number CDS780166V ;  46) DR WOLF SPINE CDS , Pack Number CDS780168P ;  47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ;  48) SPINAL FUSION CDS , Pack Number CDS780197N ;  49) SPINAL FUSION PACK, Pack Number CDS780197P ;  50) SPINAL FUSION PACK, Pack Number CDS780197Q ;  51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ;  52) LAMINECTOMY CDS , Pack Number CDS780203J ;  53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ;  54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ;  55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ;  56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ;  57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ;  58) CRANIOTOMY CDS, Pack Number CDS780206O ;  59) CRANIOTOMY CDS, Pack Number CDS780206P ;  60) CRANIOTOMY CDS, Pack Number CDS780206R ;  61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ;  62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ;  63) NEURO-LAMI CDS, Pack Number CDS780208I ;  64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ;  65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ;  66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ;  67) SPINE CDS , Pack Number CDS780228D ;  68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ;  69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ;  70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ;  71) SPINE CDS-LF, Pack Number CDS780236L ;  72) SPINE CDS-LF, Pack Number CDS780236M ;  73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ;  74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ;  75) SPINAL FUSION , Pack Number CDS860017AA;  76) SPINAL FUSION , Pack Number CDS860017AB;  77) SPINAL FUSION , Pack Number CDS860017AC;  78) FUSION CDS, Pack Number CDS860138D ;  79) FUSION CDS, Pack Number CDS860138F ;  80) FUSION CDS, Pack Number CDS860138G ;  81) LUMBAR, Pack Number CDS860170I ;  82) LUMBAR, Pack Number CDS860170J ;  83) LUMBAR, Pack Numbe",
      "text": "The FDA logged enforcement record Z-3052-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ;  2) ARTHROSCOPY TRAY, Pack Number AM110A ;  3) HIP , Pack Number BM200A ;  4) SHOULDER ARTHROSCOPY, Pack Number BM230A ;  5) KNEE ARTHROSCOPY, Pack Number BM240A ;  6) PODIATRY PACK , Pack Number BM250A ;  7) CRANIOTOMY CDS, Pack Number CDS780025AA;  8) CRANIOTOMY CDS, Pack Number CDS780025AB;  9) CRANIOTOMY CDS, Pack Number CDS780025AC;  10) CRANIOTOMY CDS, Pack Number CDS780025X ;  11) CRANIOTOMY CDS, Pack Number CDS780025Y ;  12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ;  13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ;  14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ;  15) CRANIOTOMY CDS, Pack Number CDS780046O ;  16) CRANI , Pack Number CDS780089V ;  17) CRANI , Pack Number CDS780089W ;  18) CRANI , Pack Number CDS780089X ;  19) CRANIOFACIAL CDS, Pack Number CDS780102K ;  20) CRANIOFACIAL CDS, Pack Number CDS780102L ;  21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ;  22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ;  23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ;  24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ;  25) CRANIOTOMY-LF , Pack Number CDS780111M ;  26) CRANIOTOMY-LF , Pack Number CDS780111N ;  27) CRANIOTOMY-LF , Pack Number CDS780111O ;  28) CRANIOTOMY-LF , Pack Number CDS780111P ;  29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ;  30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ;  31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH;  32) BASIC BACK CDS, Pack Number CDS780147K ;  33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ;  34) LAMINECTOMY CDS , Pack Number CDS780165L ;  35) LAMINECTOMY CDS , Pack Number CDS780165M ;  36) LAMINECTOMY CDS , Pack Number CDS780165N ;  37) LAMINECTOMY CDS , Pack Number CDS780165O ;  38) LAMINECTOMY CDS , Pack Number CDS780165Q ;  39) LAMINECTOMY CDS , Pack Number CDS780165R ;  40) CRANIOTOMY CDS, Pack Number CDS780166Q ;  41) CRANIOTOMY CDS, Pack Number CDS780166R ;  42) CRANIOTOMY CDS, Pack Number CDS780166S ;  43) CRANIOTOMY CDS, Pack Number CDS780166T ;  44) CRANIOTOMY CDS, Pack Number CDS780166U ;  45) CRANIOTOMY CDS, Pack Number CDS780166V ;  46) DR WOLF SPINE CDS , Pack Number CDS780168P ;  47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ;  48) SPINAL FUSION CDS , Pack Number CDS780197N ;  49) SPINAL FUSION PACK, Pack Number CDS780197P ;  50) SPINAL FUSION PACK, Pack Number CDS780197Q ;  51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ;  52) LAMINECTOMY CDS , Pack Number CDS780203J ;  53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ;  54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ;  55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ;  56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ;  57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ;  58) CRANIOTOMY CDS, Pack Number CDS780206O ;  59) CRANIOTOMY CDS, Pack Number CDS780206P ;  60) CRANIOTOMY CDS, Pack Number CDS780206R ;  61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ;  62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ;  63) NEURO-LAMI CDS, Pack Number CDS780208I ;  64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ;  65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ;  66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ;  67) SPINE CDS , Pack Number CDS780228D ;  68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ;  69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ;  70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ;  71) SPINE CDS-LF, Pack Number CDS780236L ;  72) SPINE CDS-LF, Pack Number CDS780236M ;  73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ;  74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ;  75) SPINAL FUSION , Pack Number CDS860017AA;  76) SPINAL FUSION , Pack Number CDS860017AB;  77) SPINAL FUSION , Pack Number CDS860017AC;  78) FUSION CDS, Pack Number CDS860138D ;  79) FUSION CDS, Pack Number CDS860138F ;  80) FUSION CDS, Pack Number CDS860138G ;  81) LUMBAR, Pack Number CDS860170I ;  82) LUMBAR, Pack Number CDS860170J ;  83) LUMBAR, Pack Numbe — 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: 00-399024X , Lot Number 19CBL066 ;  00-399024X , Lot Number 19FBI397 ;  00-399024X , Lot Number 19RBC685 ;  00-399024X , Lot Number 19HBD864 ;  00-399024X , Lot Number 19JBV149 ;  00-399024X , Lot Number 20ABH766 ;  00-399024X , Lot Number 20ABO115 ;  00-399024X , Lot Number 20CBC862 ;  AM110A , Lot Number 21GBK629 ;  AM110A , Lot Number 19HBC424 ;  AM110A , Lot Number 19JBR312 ;  AM110A , Lot Number 19KBL415 ;  AM110A , Lot Number 20ABK847 ;  AM110A , Lot Number 20GBU689 ;  AM110A , Lot Number 20HBK170 ;  AM110A , Lot Number 20LBN052 ;  AM110A , Lot Number 20LBW697 ;  AM110A , Lot Number 21CBB960 ;  AM110A , Lot Number 21FBC989 ;  BM200A , Lot Number 19EBU942 ;  BM230A , Lot Number 22CBC356 ;  BM230A , Lot Number 19DBJ049 ;  BM230A , Lot Number 19UBA244 ;  BM230A , Lot Number 19JBQ486 ;  BM230A , Lot Number 20DBF398 ;  BM230A , Lot Number 20IBB552 ;  BM230A , Lot Number 20JBR898 ;  BM240A , Lot Number 21IBR974 ;  BM240A , Lot Number 22BBC921 ;  BM240A , Lot Number 19CBF549 ;  BM240A , Lot Number 19EBV048 ;  BM240A , Lot Number 20DBS054 ;  BM240A , Lot Number 20GBU725 ;  BM240A , Lot Number 20KBS381 ;  BM240A , Lot Number 20KBX781 ;  BM240A , Lot Number 21BBJ873 ;  BM240A , Lot Number 21DBI364 ;  BM250A , Lot Number 21LBI573 ;  BM250A , Lot Number 22EBQ666 ;  BM250A , Lot Number 19HBG435 ;  BM250A , Lot Number 19JBD740 ;  BM250A , Lot Number 20ABK834 ;  BM250A , Lot Number 20DBR991 ;  BM250A , Lot Number 20EBT982 ;  BM250A , Lot Number 20GBC494 ;  BM250A , Lot Number 20GBN979 ;  BM250A , Lot Number 23LBT030 ;  BM250A , Lot Number 20KBA693 ;  BM250A , Lot Number 21ABA267 ;  BM250A , Lot Number 21ABF688 ;  BM250A , Lot Number 21BBM607 ;  CDS780025AA, Lot Number 21ABG344 ;  CDS780025AA, Lot Number 21BBI957 ;  CDS780025AA, Lot Number 21CBD927 ;  CDS780025AB, Lot Number 21HBL624 ;  CDS780025AB, Lot Number 21IBL720 ;  CDS780025AB, Lot Number 21LBU758 ;  CDS780025AB, Lot Number 22CBP174 ;  CDS780025AB, Lot Number 22EBN090 ;  CDS780025AB, Lot Number 22GBH493 ;  CDS780025AB, Lot Number 22HBB637 ;  CDS780025AC, Lot Number 22LBF788 ;  CDS780025AC, Lot Number 23CBX130 ;  CDS780025AC, Lot Number 23EBJ659 ;  CDS780025AC, Lot Number 23FBH173 ;  CDS780025AC, Lot Number 23IBI612 ;  CDS780025AC, Lot Number 23KBC083 ;  CDS780025AC, Lot Number 24BBB443 ;  CDS780025X , Lot Number 19ABP155 ;  CDS780025X , Lot Number 19ABQ093 ;  CDS780025X , Lot Number 19ABY942 ;  CDS780025X , Lot Number 19CBE111 ;  CDS780025X , Lot Number 19FBV023 ;  CDS780025Y , Lot Number 19EBO302 ;  CDS780025Y , Lot Number 19EBO396 ;  CDS780025Y , Lot Number 19KBQ760 ;  CDS780025Y , Lot Number 19KBU716 ;  CDS780025Y , Lot Number 19LBF130 ;  CDS780025Y , Lot Number 20DBO129 ;  CDS780025Y , Lot Number 20GBQ281 ;  CDS780025Y , Lot Number 20GBS047 ;  CDS780025Y , Lot Number 20JBY248 ;  CDS780045M , Lot Number 19BBH900 ;  CDS780045M , Lot Number 19CBC615 ;  CDS780045M , Lot Number 19DBC309 ;  CDS780045M , Lot Number 19EBU628 ;  CDS780045M , Lot Number 19EBU835 ;  CDS780045M , Lot Number 19GBR400 ;  CDS780045M , Lot Number 19SBC898 ;  CDS780045M , Lot Number 19VBE307 ;  CDS780045M , Lot Number 19KBN002 ;  CDS780045M , Lot Number 19KBT829 ;  CDS780045M , Lot Number 20BBJ961 ;  CDS780045M , Lot Number 20CBP221 ;  CDS780045N , Lot Number 21FBL891 ;  CDS780045N , Lot Number 21FBS507 ;  CDS780045N , Lot Number 21JBU289 ;  CDS780045N , Lot Number 21LBP574 ;  CDS780045N , Lot Number 22DBA187 ;  CDS780045N , Lot Number 22DBB694 ;  CDS780045N , Lot Number 22FBM376 ;  CDS780045N , Lot Number 22GBG444 ;  CDS780045N , Lot Number 22GBG445 ;  CDS780045N , Lot Number 22JBI816 ;  CDS780045N , Lot Number 22JBI817 ;  CDS780045N , Lot Number 22LBP661 ;  CDS780045N , Lot Number 23CBR748 ;  CDS780045N , Lot Number 20GBC500 ;  CDS780045N , Lot Number 20GBD251 ;  CDS780045N , Lot Number 20GBL415 ;  CDS780045N , Lot Number 20GBQ383 ;  CDS780045N , Lot Number 20IBN736 ;  CDS780045N , Lot Number 20JBX378 ;  CDS780045N , Lot Number 20LBC750 ;  CDS780045N , Lot Number 21BBF167 ;  CDS780045O , Lot Number 23DBP671 ;  CDS780045O , Lot Number 23EBT969 ;  CDS780045O , Lot Number 23FBU385 ;  CDS780046O , Lot Number 21GBR876 ;  CDS780046O , Lot Number 22ABW880 ;  CDS780046O , Lot Number 22BBE256 ;  CDS780046O , Lot Number 19PBB747 ;  CDS780046O , Lot Number 19FBL893 ;  CDS780046O , Lot Number 22GBY297 ;  CDS780046O , Lot Number 22JBW313 ;  CDS780046O , Lot Number 22KBH412 ;  CDS780046O , Lot Number 23ABK644 ;  CDS780046O , Lot Number 23BBA110 ;  CDS780046O , Lot Number 20DBU225 ;  CDS780046O , Lot Number 20EBD305 ;  CDS780046O , Lot Number 20EBU069 ;  CDS780046O , Lot Number 20GBK459 ;  CDS780046O , Lot Number 20GBQ343 ;  CDS780046O , Lot Number 20HBC287 ;  CDS780046O , Lot Number 20JBE768 ;  CDS780046O , Lot Number 21BBE934 ;  CDS780046O , Lot Number 21BBF841 ;  CDS780046O , Lot Number 21CBO851 ;  CDS780046O , Lot Number 21DBA629 ;  CDS780046O , Lot Number 21EBK749 ;  CDS780089V , Lot Number 19BLA484 ;  CDS780089V , Lot Number 19CLA199 ;  CDS780089V , Lot Number 19DLA506 ;  CDS780089V , Lot Number 19ELA586 ;  CDS780089V , Lot Number 19FLA443 ;  CDS780089V , Lot Number 19ILA292 ;  CDS780089V , Lot Number 19KLA012 ;  CDS780089V , Lot Number 20ALA302 ;  CDS780089V , Lot Number 20BLA154 ;  CDS780089V , Lot Number 20CLA346 ;  CDS780089V , Lot Number 20CLA377 ;  CDS780089V , Lot Number 20ELA650 ;  CDS780089V , Lot Number 20FLA192 ;  CDS780089V , Lot Number 20GLA323 ;  CDS780089V , Lot Number 20HLA062 ;  CDS780089V , Lot Number 20KLA347 ;  CDS780089V , Lot Number 20LLA017 ;  CDS780089V , Lot Number 21ALA247 ;  CDS780089W , Lot Number 21ELA499 ;  CDS780089W , Lot Number 21ELA714 ;  CDS780089W , Lot Number 21ILA014 ;  CDS780089W , Lot Number 21ILA871 ;  CDS780089X , Lot Number 21LLA724 ;  CDS780089X , Lot Number 21LLA794 ;  CDS780089X , Lot Number 21LLA962 ;  CDS780089X , Lot Number 22BLB011 ;  CDS780089X , Lot Number 22DLB117 ;  CDS780089X , Lot Number 22FLA045 ;  CDS780089X , Lot Number 22GLA532 ;  CDS780089X , Lot Number 22ILA257 ;  CDS780089X , Lot Number 22KLB074 ;  CDS780089X , Lot Number 23BLA523 ;  CDS780089X , Lot Number 23CLB179 ;  CDS780089X , Lot Number 23ELA364 ;  CDS780089X , Lot Number 23ILA376 ;  CDS780089X , Lot Number 23JLA126 ;  CDS780089X , Lot Number 23JLA704 ;  CDS780089X , Lot Number 23JLB027 ;  CDS780089X , Lot Number 24BLA505 ;  CDS780102K , Lot Number 21HBJ414 ;  CDS780102K , Lot Number 21IBA053 ;  CDS780102K , Lot Number 21JBD207 ;  CDS780102K , Lot Number 21KBC783 ;  CDS780102K , Lot Number 21KBV808 ;  CDS780102K , Lot Number 21KBV809 ;  CDS780102K , Lot Number 19DBN638 ;  CDS780102K , Lot Number 19EBN450 ;  CDS780102K , Lot Number 22GBE917 ;  CDS780102K , Lot Number 19FBN031 ;  CDS780102K , Lot Number 22HBD316 ;  CDS780102K , Lot Number 22IBE293 ;  CDS780102K , Lot Number 22IBT392 ;  CDS780102K , Lot Number 19JBE273 ;  CDS780102K , Lot Number 19JBI710 ;  CDS780102K , Lot Number 19KBR616 ;  CDS780102K , Lot Number 20BBQ409 ;  CDS780102K , Lot Number 20CBP611 ;  CDS780102K , Lot Number 20EBG877 ;  CDS780102K , Lot Number 20EBS145 ;  CDS780102K , Lot Number 20FBB178 ;  CDS780102K , Lot Number 20FBR886 ;  CDS780102K , Lot Number 20JBH667 ;  CDS780102K , Lot Number 21BBJ070 ;  CDS780102K , Lot Number 21DBH746 ;  CDS780102L , Lot Number 23ABC312 ;  CDS780102L , Lot Number 23DBT155 ;  CDS780102L , Lot Number 23GBS654 ;  CDS780104L , Lot Number 22BBD890 ;  CDS780104L , Lot Number 22OBL743 ;  CDS780104L , Lot Number 22IBR905 ;  CDS780104L , Lot Number 22KBB817 ;  CDS780104L , Lot Number 23ABM657 ;  CDS780104L , Lot Number 23CBH325 ;  CDS780104L , Lot Number 23DBT179 ;  CDS780104L , Lot Number 23IBS971 ;  CDS780104L , Lot Number 23IBT047 ;  CDS780104L , Lot Number 23LBE523 ;  CDS780104L , Lot Number 23LBE671 ;  CDS780105K , Lot Number 21FBN763 ;  CDS780105K , Lot Number 21IBS477 ;  CDS780105K , Lot Number 21JBH424 ;  CDS780105K , Lot Number 19CBB271 ;  CDS780105K , Lot Number 19DBI491 ;  CDS780105K , Lot Number 19EBB829 ;  CDS780105K , Lot Number 19EBN421 ;  CDS780105K , Lot Number 19FBD123 ;  CDS780105K , Lot Number 19GBC919 ;  CDS780105K , Lot Number 19IBH668 ;  CDS780105K , Lot Number 19JBR671 ;  CDS780105K , Lot Number 20ABE319 ;  CDS780105K , Lot Number 20CBC162 ;  CDS780105K , Lot Number 20FBF445 ;  CDS780105K , Lot Number 20GBD844 ;  CDS780105K , Lot Number 20IBD944 ;  CDS780105K , Lot Number 20LBD264 ;  CDS780105K , Lot Number 21ABW337 ;  CDS780105K , Lot Number 21DBF100 ;  CDS780105L , Lot Number 22CBG769 ;  CDS780105L , Lot Number 22DBI992 ;  CDS780105L , Lot Number 22EBE861 ;  CDS780105L , Lot Number 22FBW180 ;  CDS780105L , Lot Number 22GBA843 ;  CDS780105L , Lot Number 22HBI798 ;  CDS780105L , Lot Number 22IBA597 ;  CDS780105L , Lot Number 23ABD934 ;  CDS780105L , Lot Number 23ABE600 ;  CDS780105L , Lot Number 23DBD675 ;  CDS780105L , Lot Number 23FBA008 ;  CDS780105L , Lot Number 23FBA141 ;  CDS780105L , Lot Number 23HBQ153 ;  CDS780105L , Lot Number 23JBL140 ;  CDS780105L , Lot Number 23LBQ382 ;  CDS780109P , Lot Number 23KBM336 ;  CDS780109P , Lot Number 24ABL060 ;  CDS780111M , Lot Number 19BBO520 ;  CDS780111M , Lot Number 19DBD837 ;  CDS780111M , Lot Number 19GBS443 ;  CDS780111M , Lot Number 19IBX646 ;  CDS780111M , Lot Number 19JBY659 ;  CDS780111M , Lot Number 20DBS612 ;  CDS780111N , Lot Number 21HBS235 ;  CDS780111N , Lot Number 21HBS239 ;  CDS780111N , Lot Number 20HBP056 ;  CDS780111N , Lot Number 20IBC457 ;  CDS780111N , Lot Number 20IBN729 ;  CDS780111N , Lot Number 20LBP958 ;  CDS780111N , Lot Number 20XBI191 ;  CDS780111N , Lot Number 21DBP206 ;  CDS780111O , Lot Number 22BBS177 ;  CDS780111O , Lot Number 22OBD871 ;  CDS780111O , Lot Number 22DBP856 ;  CDS780111O , Lot Number 22FBY057 ;  CDS780111O , Lot Number 22KBD815 ;  CDS780111O , Lot Number 23ABR378 ;  CDS780111O , Lot Number 23BBT628 ;  CDS780111O , Lot Number 23IBK502 ;  CDS780111O , Lot Number 23JBP367 ;  CDS780111P , Lot Number 24ABL026 ;  CDS780111P , Lot Number 24BBK181 ;  CDS780119U , Lot Number 21HBB379 ;  CDS780119U , Lot Number 21IBV579 ;  CDS780119U , Lot Number 21KBV760 ;  CDS780119U , Lot Number 21KBV761 ;  CDS780119U , Lot Number 22CBL018 ;  CDS780119U , Lot Number 20HBC289 ;  CDS780119U , Lot Number 20JBX601 ;  CDS780119U , Lot Number 21ABJ206 ;  CDS780119U , Lot Number 21CBC828 ;  CDS780119V , Lot Number 22DBN874 ;  CDS780119V , Lot Number 22FBU189 ;  CDS780119V , Lot Number 22HBO015 ;  CDS780119V , Lot Number 22KBN442 ;  CDS780119V , Lot Number 23ABF941 ;  CDS780119V , Lot Number 23BBQ326 ;  CDS780119V , Lot Number 23DBE182 ;  CDS780119V , Lot Number 23GBQ904 ;  CDS780119V , Lot Number 23JBS979 ;  CDS780119V , Lot Number 23LBD741 ;  CDS780119V , Lot Number 24ABF767 ;  CDS780119V , Lot Number 24BBK027 ;  CDS780119VH, Lot Number 22DBN874 ;  CDS780119VH, Lot Number 22FBU189 ;  CDS780119VH, Lot Number 22HBO015 ;  CDS780119VH, Lot Number 22KBN442 ;  CDS780119VH, Lot Number 23ABF941 ;  CDS780119VH, Lot Number 23BBQ326 ;  CDS780119VH, Lot Number 23DBE182 ;  CDS780119VH, Lot Number 23GBQ904 ;  CDS780119VH, Lot Number 23JBS979 ;  CDS780119VH, Lot Number 23LBD741 ;  CDS780119VH, Lot Number 24ABF767 ;  CDS780119VH, Lot Number 24BBK027 ;  CDS780147K , Lot Number 19ABP440 ; 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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-3052-2024&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-3052-2024&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-3052-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3052-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3052-2024&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-3052-2024&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-3052-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
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        "adjudged": false,
        "operative": true
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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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          "item": {
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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.",
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 CDS860017AB, Lot Number 19JBH120 ;  CDS860017AB, Lot Number 19VBA707 ;  CDS860017AB, Lot Number 19VBC059 ;  CDS860017AB, Lot Number 20ABJ934 ;  CDS860017AB, Lot Number 20DBD785 ;  CDS860017AB, Lot Number 20HBC019 ;  CDS860017AB, Lot Number 20HBQ811 ;  CDS860017AB, Lot Number 20JBR263 ;  CDS860017AB, Lot Number 20XBA403 ;  CDS860017AB, Lot Number 21ABM097 ;  CDS860017AC, Lot Number 21LBJ666 ;  CDS860017AC, Lot Number 22ABF962 ;  CDS860017AC, Lot Number 22DBI012 ;  CDS860017AC, Lot Number 22GBM024 ;  CDS860017AC, Lot Number 22IBA866 ;  CDS860017AC, Lot Number 22IBA867 ;  CDS860017AC, Lot Number 22IBI049 ;  CDS860017AC, Lot Number 23ABA853 ;  CDS860017AC, Lot Number 23ABN816 ;  CDS860017AC, Lot Number 23BBD149 ;  CDS860017AC, Lot Number 23FBN506 ;  CDS860017AC, Lot Number 23GBF835 ;  CDS860017AC, Lot Number 23GBP215 ;  CDS860017AC, Lot Number 23GBS036 ;  CDS860017AC, Lot Number 24ABC731 ;  CDS860017AC, Lot Number 24ABP257 ;  CDS860017AC, Lot Number 21CBF910 ;  CDS860138D , Lot Number 19ABQ136 ;  CDS860138D , Lot Number 19BBN817 ;  CDS860138D , Lot Number 19EBI657 ;  CDS860138D , Lot Number 19IBW694 ;  CDS860138D , Lot Number 19LBP292 ;  CDS860138F , Lot Number 20CBB526 ;  CDS860138F , Lot Number 20DBG756 ;  CDS860138F , Lot Number 20LBV775 ;  CDS860138G , Lot Number 21DBC090 ;  CDS860170I , Lot Number 19ABF804 ;  CDS860170I , Lot Number 19BBQ437 ;  CDS860170J , Lot Number 21GBA985 ;  CDS860170J , Lot Number 21IBJ214 ;  CDS860170J , Lot Number 21KBB575 ;  CDS860170J , Lot Number 21KBU565 ;  CDS860170J , Lot Number 21LBN475 ;  CDS860170J , Lot Number 19FBN707 ;  CDS860170J , Lot Number 19GBL869 ;  CDS860170J , Lot Number 19GBN342 ;  CDS860170J , Lot Number 22HBW286 ;  CDS860170J , Lot Number 19SBB095 ;  CDS860170J , Lot Number 22IBE670 ;  CDS860170J , Lot Number 22JBH330 ;  CDS860170J , Lot Number 19TBC537 ;  CDS860170J , Lot Number 22LBC689 ;  CDS860170J , Lot Number 19JBE704 ;  CDS860170J , Lot Number 23ABC236 ;  CDS860170J , Lot Number 23ABK729 ;  CDS860170J , Lot Number 19KBQ805 ;  CDS860170J , Lot Number 19LBG156 ;  CDS860170J , Lot Number 23DBD487 ;  CDS860170J , Lot Number 20ABS665 ;  CDS860170J , Lot Number 23EBV682 ;  CDS860170J , Lot Number 20BBW633 ;  CDS860170J , Lot Number 23FBU593 ;  CDS860170J , Lot Number 20DBK836 ;  CDS860170J , Lot Number 20EBC886 ;  CDS860170J , Lot Number 20FBJ566 ;  CDS860170J , Lot Number 23JBH129 ;  CDS860170J , Lot Number 20GBQ824 ;  CDS860170J , Lot Number 20LBR262 ;  CDS860170J , Lot Number 21BBM002 ;  CDS860170J , Lot Number 21EBC486 ;  CDS860170K , Lot Number 23KBS472 ;  CDS940047AA, Lot Number 19BDC968 ;  CDS940047AA, Lot Number 19DDC046 ;  CDS940047AA, Lot Number 19DDC430 ;  CDS940047AA, Lot Number 19GDA332 ;  CDS940047AA, Lot Number 19HDC228 ;  CDS940047AA, Lot Number 19JDC076 ;  CDS940047AA, Lot Number 19LDB760 ;  CDS940047AA, Lot Number 20CDC265 ;  CDS940047AB, Lot Number 20GDA820 ;  CDS940047AB, Lot Number 20IDA834 ;  CDS940047AB, Lot Number 20KDA177 ;  CDS940047AB, Lot Number 20LDA287 ;  CDS940047AB, Lot Number 21CDB743 ;  CDS940047AC, Lot Number 21FDA359 ;  CDS940047AC, Lot Number 21HDA380 ;  CDS940047AC, Lot Number 21HDB718 ;  CDS940047AC, Lot Number 22CDB855 ;  CDS940047AC, Lot Number 22DDA410 ;  CDS940047AC, Lot Number 22DDA885 ;  CDS940047AC, Lot Number 22EDA610 ;  CDS940047AD, Lot Number 22GDB423 ;  CDS940047AF, Lot Number 22KDA050 ;  CDS940047AF, Lot Number 23BDA010 ;  CDS940047AF, Lot Number 23CDB620 ;  CDS940047AF, Lot Number 23DDC114 ;  CDS940047AF, Lot Number 23FDA378 ;  CDS940047AF, Lot Number 23GDB923 ;  CDS940047AF, Lot Number 23HDB417 ;  CDS940047AF, Lot Number 23IDA521 ;  CDS940047AG, Lot Number 23KDA158 ;  CDS940047AG, Lot Number 24ADA404 ;  CDS940047AI, Lot Number 24BDA533 ;  CDS940047AI, Lot Number 24CDA865 ;  CDS940047AI, Lot Number 24CDB447 ;  CDS940048AB, Lot Number 19BDC637 ;  CDS940048AB, Lot Number 19DDA396 ;  CDS940048AB, Lot Number 19EDD473 ;  CDS940048AB, Lot Number 19IDC112 ;  CDS940048AB, Lot Number 19KDA804 ;  CDS940048AB, Lot Number 20ADA910 ;  CDS940048AB, Lot Number 20CDC240 ;  CDS940048AB, Lot Number 20DDB674 ;  CDS940048AC, Lot Number 20GDB807 ;  CDS940048AC, Lot Number 20IDA861 ;  CDS940048AC, Lot Number 20KDB463 ;  CDS940048AC, Lot Number 21ADB198 ;  CDS940048AC, Lot Number 21CDB557 ;  CDS940048AC, Lot Number 21CDC438 ;  CDS940048AD, Lot Number 21HDB799 ;  CDS940048AD, Lot Number 21HDC479 ;  CDS940048AD, Lot Number 21JDB116 ;  CDS940048AF, Lot Number 22EDB749 ;  CDS940048AG, Lot Number 22IDA258 ;  CDS940048AG, Lot Number 22JDB464 ;  CDS940048AG, Lot Number 23BDA005 ;  CDS940048AG, Lot Number 23CDA075 ;  CDS940048AG, Lot Number 23CDB146 ;  CDS940048AG, Lot Number 23FDA460 ;  CDS940048AG, Lot Number 23HDA534 ;  CDS940048AG, Lot Number 23IDA944 ;  CDS940048AI, Lot Number 23KDA886 ;  CDS940048AI, Lot Number 24ADA827 ;  CDS940060AA, Lot Number 19BBJ734 ;  CDS940060AA, Lot Number 19BBU037 ;  CDS940060AA, Lot Number 19DBD751 ;  CDS940060AB, Lot Number 19EBT410 ;  CDS940060AB, Lot Number 19FBD674 ;  CDS940060AB, Lot Number 19GBM852 ;  CDS940060AB, Lot Number 19TBE517 ;  CDS940060AB, Lot Number 19IBX513 ;  CDS940060AC, Lot Number 19KBI891 ;  CDS940060AC, Lot Number 19LBT074 ;  CDS940060AC, Lot Number 20ABO601 ;  CDS940060AD, Lot Number 20DBB480 ;  CDS940060AD, Lot Number 20FBT722 ;  CDS940060AD, Lot Number 20JBH314 ;  CDS940060AD, Lot Number 20LBF231 ;  CDS940060AF, Lot Number 21BBI970 ;  CDS940060AG, Lot Number 21FBK160 ;  CDS940060AG, Lot Number 21GBR899 ;  CDS940060AG, Lot Number 21GBR900 ;  CDS940060AG, Lot Number 21JBF924 ;  CDS940060AG, Lot Number 21KBH178 ;  CDS940060AG, Lot Number 22FBB236 ;  CDS940060AG, Lot Number 22FBG732 ;  CDS940060AG, Lot Number 22GBI847 ;  CDS940060AG, Lot Number 21DBM270 ;  CDS940060AI, Lot Number 22HBS769 ;  CDS940060AI, Lot Number 22JBU536 ;  CDS940060AI, Lot Number 22KBG389 ;  CDS940060AI, Lot Number 22LBE929 ;  CDS940060AI, Lot Number 23ABG372 ;  CDS940060AI, Lot Number 23CBM507 ;  CDS940060AI, Lot Number 23CBU504 ;  CDS940060AI, Lot Number 23EBD027 ;  CDS940060AI, Lot Number 23FBF613 ;  CDS940060AI, Lot Number 23FBP578 ;  CDS940060AI, Lot Number 23IBD724 ;  CDS940060AI, Lot Number 23IBQ758 ;  CDS940060AI, Lot Number 23KBT052 ;  CDS940064Q , Lot Number 19CBJ837 ;  CDS940064Q , Lot Number 19DBL652 ;  CDS940064Q , Lot Number 19QBB889 ;  CDS940064Q , Lot Number 19GBG892 ;  CDS940064Q , Lot Number 19HBE965 ;  CDS940064Q , Lot Number 19IBP862 ;  CDS940064Q , Lot Number 19IBS356 ;  CDS940064Q , Lot Number 19VBB936 ;  CDS940064Q , Lot Number 19VBH131 ;  CDS940064Q , Lot Number 19KBQ727 ;  CDS940080T , Lot Number 21HBR427 ;  CDS940080T , Lot Number 21IBL992 ;  CDS940080T , Lot Number 22ABF188 ;  CDS940080T , Lot Number 22BBB799 ;  CDS940080T , Lot Number 19CBA003 ;  CDS940080T , Lot Number 19CBR575 ;  CDS940080T , Lot Number 22DBJ461 ;  CDS940080T , Lot Number 22DBM767 ;  CDS940080T , Lot Number 19PBC872 ;  CDS940080T , Lot Number 22GBO450 ;  CDS940080T , Lot Number 19GBA676 ;  CDS940080T , Lot Number 19IBT426 ;  CDS940080T , Lot Number 20ABY918 ;  CDS940080T , Lot Number 20BBP131 ;  CDS940080T , Lot Number 20DBQ011 ;  CDS940080T , Lot Number 20GBJ660 ;  CDS940080T , Lot Number 21ABK429 ;  CDS940080T , Lot Number 21ABS987 ;  CDS940080T , Lot Number 21BBG965 ;  CDS940080T , Lot Number 21EBH619 ;  CDS940080U , Lot Number 22JBJ442 ;  CDS940080V , Lot Number 23CBG228 ;  CDS940080V , Lot Number 23EBD087 ;  CDS940080W , Lot Number 23EBV659 ;  CDS940080W , Lot Number 23KBB662 ;  CDS940080W , Lot Number 23KBX234 ;  CDS940087AC, Lot Number 20ABC867 ;  CDS940087AC, Lot Number 20ABU027 ;  CDS940087AC, Lot Number 20DBM203 ;  CDS940087AC, Lot Number 20FBT720 ;  CDS940087AC, Lot Number 20HBE580 ;  CDS940087AC, Lot Number 20HBV401 ;  CDS940087AD, Lot Number 20KBE315 ;  CDS940087AD, Lot Number 20LBU707 ;  CDS940087AG, Lot Number 21EBC900 ;  CDS940087AI, Lot Number 21GBI183 ;  CDS940087AI, Lot Number 21IBJ260 ;  CDS940087AI, Lot Number 21JBF936 ;  CDS940087AI, Lot Number 21KBH163 ;  CDS940087AI, Lot Number 22BBY060 ;  CDS940087AI, Lot Number 22EBA274 ;  CDS940087AI, Lot Number 22EBF695 ;  CDS940087AI, Lot Number 22EBG548 ;  CDS940087AI, Lot Number 22GBE442 ;  CDS940087AJ, Lot Number 22HBO525 ;  CDS940087AK, Lot Number 22LBG216 ;  CDS940087AL, Lot Number 23ABB068 ;  CDS940087AL, Lot Number 23DBN024 ;  CDS940087AL, Lot Number 23EBL944 ;  CDS940087AL, Lot Number 23FBI843 ;  CDS940087AL, Lot Number 23HBP378 ;  CDS940087AL, Lot Number 23IBD027 ;  CDS940087AL, Lot Number 23IBW076 ;  CDS940087AL, Lot Number 23KBN905 ;  CDS940087AL, Lot Number 23KBP002 ;  CDS940088M , Lot Number 19BBU013 ;  CDS940088M , Lot Number 19HBQ641 ;  CDS940088M , Lot Number 19HBZ093 ;  CDS940088M , Lot Number 19IBX779 ;  CDS940088M , Lot Number 19VBA573 ;  CDS940091Q , Lot Number 19PBA068 ;  CDS940218L , Lot Number 21LBO374 ;  CDS940218L , Lot Number 22BBF255 ;  CDS940218L , Lot Number 22CBC343 ;  CDS940218L , Lot Number 22DBK722 ;  CDS940218L , Lot Number 22GBB125 ;  CDS940218L , Lot Number 19FBJ791 ;  CDS940218L , Lot Number 22HBF657 ;  CDS940218L , Lot Number 22HBS730 ;  CDS940218L , Lot Number 19KBC397 ;  CDS940218L , Lot Number 20BBA602 ;  CDS940218L , Lot Number 20BBW907 ;  CDS940218L , Lot Number 20GBS036 ;  CDS940218L , Lot Number 20IBL823 ;  CDS940218M , Lot Number 23FBD940 ;  CDS940242J , Lot Number 22FBH313 ;  CDS940242J , Lot Number 22GBT200 ;  CDS940242J , Lot Number 22JBC106 ;  CDS940242J , Lot Number 23ABE598 ;  CDS940242J , Lot Number 23ABF766 ;  CDS940242J ,",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}