{
  "@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-3019-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) MYELOGRAM PACK, Pack Number 00-399025L ;  2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;  3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;  4) THORACENTESIS TRAY, Pack Number 00-400616J ;  5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ;  6) PROCEDURE PACK-LF , Pack Number 00-401585M ;  7) PTCA PACK , Pack Number 00-401800F ;  8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ;  9) PICC LINE TRAY, Pack Number 00-401993N ;  10) ARTERIOGRAM TRAY, Pack Number 00-402001S ;  11) CARDIAC CATH PACK , Pack Number 00-500502L ;  12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N;  13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O;  14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P;  15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672;  16) KIT ANGIO CSTM, Pack Number 135169;  17) KIT NEURO 2-UIC, Pack Number 138557;  18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ;  19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356;  20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1;  21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ;  22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ;  23) PROCEDURAL ACC KIT, Pack Number 20060921 ;  24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ;  25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ;  26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ;  27) BASIC PROCEDURE PACK, Pack Number 7790 ;  28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ;  29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ;  30) PROCEDURE PACK, RF, Pack Number 7795 ;  31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ;  32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ;  33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ;  34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ;  35) NEONATAL DRAWER 6 , Pack Number ACC010653;  36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A;  37) RADIAL TRAY , Pack Number AM140A ;  38) RADIAL TRAY , Pack Number AM140B ;  39) SET UP TRAY , Pack Number AM235A ;  40) PACK SET UP , Pack Number AM235B ;  41) HEAD & NECK TRAY, Pack Number AM310A ;  42) 18GX6  FEMORAL ART MAX BARRIER KIT, Pack Number ART1230;  43) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  44) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;  45) 20GX3\" RADIAL ART LINE KIT, Pack Number ART970A;  46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110;  47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686;  48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710;  49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ;  50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ;  51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ;  52) CYSTO PROCEDURE , Pack Number CDS760062O ;  53) NEURO CDS , Pack Number CDS780056M ;  54) SHUNT CDS-LF, Pack Number CDS780103J ;  55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ;  56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ;  57) UVALDE C-SECTION CDS, Pack Number CDS820116D ;  58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ;  59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ;  60) AAA CDS , Pack Number CDS840076AB;  61) AAA CDS , Pack Number CDS840076X ;  62) AAA CDS , Pack Number CDS840076Y ;  63) OFF PUMP CABG CDS , Pack Number CDS840087AA;  64) OFF PUMP CABG CDS , Pack Number CDS840087AC;  65) OPEN HEART, Pack Number CDS840150Q ;  66) VALVE PACK, Pack Number CDS840187R ;  67) AV FISTULA PACK , Pack Number CDS840188L ;  68) MAJOR VASCULAR PACK , Pack Number CDS840195S ;  69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ;  70) FETOSCOPY CDS-LF, Pack Number CDS840215N ;  71) MAJOR VASCULAR-LF , Pack Number CDS840232J ;  72) AVF-LF, Pack Number CDS840233D ;  73) AVF-LF, Pack Number CDS840233F ;  74) AVF-LF, Pack Number CDS840233G ;  75) GENERAL AAA #11-RF, Pack Number CDS840261AA;  76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ;  77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ;  78) THOROCOTOMY , Pack Number CDS840354N ;  79) THOROCOTOMY , Pack Number CDS840354O ;  80) THORO",
  "description": "FDA recall Z-3019-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) MYELOGRAM PACK, Pack Number 00-399025L ;  2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;  3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;  4) THORACENTESIS TRAY, Pack Number 00-400616J ;  5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ;  6) PROCEDURE PACK-LF , Pack Number 00-401585M ;  7) PTCA PACK , Pack Number 00-401800F ;  8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ;  9) PICC LINE TRAY, Pack Number 00-401993N ;  10) ARTERIOGRAM TRAY, Pack Number 00-402001S ;  11) CARDIAC CATH PACK , Pack Number 00-500502L ;  12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N;  13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O;  14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P;  15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672;  16) KIT ANGIO CSTM, Pack Number 135169;  17) KIT NEURO 2-UIC, Pack Number 138557;  18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ;  19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356;  20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1;  21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ;  22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ;  23) PROCEDURAL ACC KIT, Pack Number 20060921 ;  24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ;  25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ;  26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ;  27) BASIC PROCEDURE PACK, Pack Number 7790 ;  28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ;  29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ;  30) PROCEDURE PACK, RF, Pack Number 7795 ;  31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ;  32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ;  33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ;  34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ;  35) NEONATAL DRAWER 6 , Pack Number ACC010653;  36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A;  37) RADIAL TRAY , Pack Number AM140A ;  38) RADIAL TRAY , Pack Number AM140B ;  39) SET UP TRAY , Pack Number AM235A ;  40) PACK SET UP , Pack Number AM235B ;  41) HEAD & NECK TRAY, Pack Number AM310A ;  42) 18GX6  FEMORAL ART MAX BARRIER KIT, Pack Number ART1230;  43) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  44) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;  45) 20GX3\" RADIAL ART LINE KIT, Pack Number ART970A;  46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110;  47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686;  48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710;  49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ;  50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ;  51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ;  52) CYSTO PROCEDURE , Pack Number CDS760062O ;  53) NEURO CDS , Pack Number CDS780056M ;  54) SHUNT CDS-LF, Pack Number CDS780103J ;  55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ;  56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ;  57) UVALDE C-SECTION CDS, Pack Number CDS820116D ;  58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ;  59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ;  60) AAA CDS , Pack Number CDS840076AB;  61) AAA CDS , Pack Number CDS840076X ;  62) AAA CDS , Pack Number CDS840076Y ;  63) OFF PUMP CABG CDS , Pack Number CDS840087AA;  64) OFF PUMP CABG CDS , Pack Number CDS840087AC;  65) OPEN HEART, Pack Number CDS840150Q ;  66) VALVE PACK, Pack Number CDS840187R ;  67) AV FISTULA PACK , Pack Number CDS840188L ;  68) MAJOR VASCULAR PACK , Pack Number CDS840195S ;  69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ;  70) FETOSCOPY CDS-LF, Pack Number CDS840215N ;  71) MAJOR VASCULAR-LF , Pack Number CDS840232J ;  72) AVF-LF, Pack Number CDS840233D ;  73) AVF-LF, Pack Number CDS840233F ;  74) AVF-LF, Pack Number CDS840233G ;  75) GENERAL AAA #11-RF, Pack Number CDS840261AA;  76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ;  77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ;  78) THOROCOTOMY , Pack Number CDS840354N ;  79) THOROCOTOMY , Pack Number CDS840354O ;  80) THORO (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-3019-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) MYELOGRAM PACK, Pack Number 00-399025L ;  2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;  3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;  4) THORACENTESIS TRAY, Pack Number 00-400616J ;  5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ;  6) PROCEDURE PACK-LF , Pack Number 00-401585M ;  7) PTCA PACK , Pack Number 00-401800F ;  8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ;  9) PICC LINE TRAY, Pack Number 00-401993N ;  10) ARTERIOGRAM TRAY, Pack Number 00-402001S ;  11) CARDIAC CATH PACK , Pack Number 00-500502L ;  12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N;  13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O;  14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P;  15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672;  16) KIT ANGIO CSTM, Pack Number 135169;  17) KIT NEURO 2-UIC, Pack Number 138557;  18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ;  19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356;  20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1;  21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ;  22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ;  23) PROCEDURAL ACC KIT, Pack Number 20060921 ;  24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ;  25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ;  26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ;  27) BASIC PROCEDURE PACK, Pack Number 7790 ;  28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ;  29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ;  30) PROCEDURE PACK, RF, Pack Number 7795 ;  31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ;  32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ;  33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ;  34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ;  35) NEONATAL DRAWER 6 , Pack Number ACC010653;  36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A;  37) RADIAL TRAY , Pack Number AM140A ;  38) RADIAL TRAY , Pack Number AM140B ;  39) SET UP TRAY , Pack Number AM235A ;  40) PACK SET UP , Pack Number AM235B ;  41) HEAD & NECK TRAY, Pack Number AM310A ;  42) 18GX6  FEMORAL ART MAX BARRIER KIT, Pack Number ART1230;  43) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  44) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;  45) 20GX3\" RADIAL ART LINE KIT, Pack Number ART970A;  46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110;  47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686;  48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710;  49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ;  50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ;  51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ;  52) CYSTO PROCEDURE , Pack Number CDS760062O ;  53) NEURO CDS , Pack Number CDS780056M ;  54) SHUNT CDS-LF, Pack Number CDS780103J ;  55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ;  56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ;  57) UVALDE C-SECTION CDS, Pack Number CDS820116D ;  58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ;  59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ;  60) AAA CDS , Pack Number CDS840076AB;  61) AAA CDS , Pack Number CDS840076X ;  62) AAA CDS , Pack Number CDS840076Y ;  63) OFF PUMP CABG CDS , Pack Number CDS840087AA;  64) OFF PUMP CABG CDS , Pack Number CDS840087AC;  65) OPEN HEART, Pack Number CDS840150Q ;  66) VALVE PACK, Pack Number CDS840187R ;  67) AV FISTULA PACK , Pack Number CDS840188L ;  68) MAJOR VASCULAR PACK , Pack Number CDS840195S ;  69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ;  70) FETOSCOPY CDS-LF, Pack Number CDS840215N ;  71) MAJOR VASCULAR-LF , Pack Number CDS840232J ;  72) AVF-LF, Pack Number CDS840233D ;  73) AVF-LF, Pack Number CDS840233F ;  74) AVF-LF, Pack Number CDS840233G ;  75) GENERAL AAA #11-RF, Pack Number CDS840261AA;  76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ;  77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ;  78) THOROCOTOMY , Pack Number CDS840354N ;  79) THOROCOTOMY , Pack Number CDS840354O ;  80) THORO",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3019-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3019-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) MYELOGRAM PACK, Pack Number 00-399025L ;  2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;  3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;  4) THORACENTESIS TRAY, Pack Number 00-400616J ;  5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ;  6) PROCEDURE PACK-LF , Pack Number 00-401585M ;  7) PTCA PACK , Pack Number 00-401800F ;  8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ;  9) PICC LINE TRAY, Pack Number 00-401993N ;  10) ARTERIOGRAM TRAY, Pack Number 00-402001S ;  11) CARDIAC CATH PACK , Pack Number 00-500502L ;  12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N;  13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O;  14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P;  15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672;  16) KIT ANGIO CSTM, Pack Number 135169;  17) KIT NEURO 2-UIC, Pack Number 138557;  18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ;  19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356;  20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1;  21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ;  22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ;  23) PROCEDURAL ACC KIT, Pack Number 20060921 ;  24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ;  25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ;  26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ;  27) BASIC PROCEDURE PACK, Pack Number 7790 ;  28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ;  29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ;  30) PROCEDURE PACK, RF, Pack Number 7795 ;  31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ;  32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ;  33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ;  34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ;  35) NEONATAL DRAWER 6 , Pack Number ACC010653;  36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A;  37) RADIAL TRAY , Pack Number AM140A ;  38) RADIAL TRAY , Pack Number AM140B ;  39) SET UP TRAY , Pack Number AM235A ;  40) PACK SET UP , Pack Number AM235B ;  41) HEAD & NECK TRAY, Pack Number AM310A ;  42) 18GX6  FEMORAL ART MAX BARRIER KIT, Pack Number ART1230;  43) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  44) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;  45) 20GX3\" RADIAL ART LINE KIT, Pack Number ART970A;  46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110;  47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686;  48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710;  49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ;  50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ;  51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ;  52) CYSTO PROCEDURE , Pack Number CDS760062O ;  53) NEURO CDS , Pack Number CDS780056M ;  54) SHUNT CDS-LF, Pack Number CDS780103J ;  55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ;  56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ;  57) UVALDE C-SECTION CDS, Pack Number CDS820116D ;  58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ;  59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ;  60) AAA CDS , Pack Number CDS840076AB;  61) AAA CDS , Pack Number CDS840076X ;  62) AAA CDS , Pack Number CDS840076Y ;  63) OFF PUMP CABG CDS , Pack Number CDS840087AA;  64) OFF PUMP CABG CDS , Pack Number CDS840087AC;  65) OPEN HEART, Pack Number CDS840150Q ;  66) VALVE PACK, Pack Number CDS840187R ;  67) AV FISTULA PACK , Pack Number CDS840188L ;  68) MAJOR VASCULAR PACK , Pack Number CDS840195S ;  69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ;  70) FETOSCOPY CDS-LF, Pack Number CDS840215N ;  71) MAJOR VASCULAR-LF , Pack Number CDS840232J ;  72) AVF-LF, Pack Number CDS840233D ;  73) AVF-LF, Pack Number CDS840233F ;  74) AVF-LF, Pack Number CDS840233G ;  75) GENERAL AAA #11-RF, Pack Number CDS840261AA;  76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ;  77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ;  78) THOROCOTOMY , Pack Number CDS840354N ;  79) THOROCOTOMY , Pack Number CDS840354O ;  80) THORO",
      "text": "The FDA logged enforcement record Z-3019-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) MYELOGRAM PACK, Pack Number 00-399025L ;  2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ;  3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N;  4) THORACENTESIS TRAY, Pack Number 00-400616J ;  5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ;  6) PROCEDURE PACK-LF , Pack Number 00-401585M ;  7) PTCA PACK , Pack Number 00-401800F ;  8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ;  9) PICC LINE TRAY, Pack Number 00-401993N ;  10) ARTERIOGRAM TRAY, Pack Number 00-402001S ;  11) CARDIAC CATH PACK , Pack Number 00-500502L ;  12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N;  13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O;  14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P;  15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672;  16) KIT ANGIO CSTM, Pack Number 135169;  17) KIT NEURO 2-UIC, Pack Number 138557;  18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ;  19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356;  20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1;  21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ;  22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ;  23) PROCEDURAL ACC KIT, Pack Number 20060921 ;  24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ;  25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ;  26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ;  27) BASIC PROCEDURE PACK, Pack Number 7790 ;  28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ;  29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ;  30) PROCEDURE PACK, RF, Pack Number 7795 ;  31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ;  32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ;  33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ;  34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ;  35) NEONATAL DRAWER 6 , Pack Number ACC010653;  36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A;  37) RADIAL TRAY , Pack Number AM140A ;  38) RADIAL TRAY , Pack Number AM140B ;  39) SET UP TRAY , Pack Number AM235A ;  40) PACK SET UP , Pack Number AM235B ;  41) HEAD & NECK TRAY, Pack Number AM310A ;  42) 18GX6  FEMORAL ART MAX BARRIER KIT, Pack Number ART1230;  43) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  44) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;  45) 20GX3\" RADIAL ART LINE KIT, Pack Number ART970A;  46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110;  47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686;  48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710;  49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ;  50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ;  51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ;  52) CYSTO PROCEDURE , Pack Number CDS760062O ;  53) NEURO CDS , Pack Number CDS780056M ;  54) SHUNT CDS-LF, Pack Number CDS780103J ;  55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ;  56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ;  57) UVALDE C-SECTION CDS, Pack Number CDS820116D ;  58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ;  59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ;  60) AAA CDS , Pack Number CDS840076AB;  61) AAA CDS , Pack Number CDS840076X ;  62) AAA CDS , Pack Number CDS840076Y ;  63) OFF PUMP CABG CDS , Pack Number CDS840087AA;  64) OFF PUMP CABG CDS , Pack Number CDS840087AC;  65) OPEN HEART, Pack Number CDS840150Q ;  66) VALVE PACK, Pack Number CDS840187R ;  67) AV FISTULA PACK , Pack Number CDS840188L ;  68) MAJOR VASCULAR PACK , Pack Number CDS840195S ;  69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ;  70) FETOSCOPY CDS-LF, Pack Number CDS840215N ;  71) MAJOR VASCULAR-LF , Pack Number CDS840232J ;  72) AVF-LF, Pack Number CDS840233D ;  73) AVF-LF, Pack Number CDS840233F ;  74) AVF-LF, Pack Number CDS840233G ;  75) GENERAL AAA #11-RF, Pack Number CDS840261AA;  76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ;  77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ;  78) THOROCOTOMY , Pack Number CDS840354N ;  79) THOROCOTOMY , Pack Number CDS840354O ;  80) THORO — 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: 00-399025L , Lot Number 23LMB058 ;  00-399025L , Lot Number 23LMG684 ;  00-399025L , Lot Number 23LMH827 ;  00-399025L , Lot Number 24AMC410 ;  00-399025L , Lot Number 19ELA658 ;  00-399025L , Lot Number 19KLA410 ;  00-399025L , Lot Number 20BLA276 ;  00-399025L , Lot Number 20CLA517 ;  00-399025L , Lot Number 20GLA372 ;  00-399025L , Lot Number 20JLA514 ;  00-399025L , Lot Number 21ELA301 ;  00-399025L , Lot Number 21HLA415 ;  00-399025L , Lot Number 21JLA793 ;  00-399025L , Lot Number 22CLA145 ;  00-399025L , Lot Number 22ELA199 ;  00-399025L , Lot Number 22ELA628 ;  00-399025L , Lot Number 22JLA233 ;  00-399025L , Lot Number 23ALA823 ;  00-399025L , Lot Number 23ELA753 ;  00-399025L , Lot Number 23ELB229 ;  00-399025L , Lot Number 23JLA541 ;  00-399025L , Lot Number 23KLA374 ;  00-399227G , Lot Number 21FBH746 ;  00-399227G , Lot Number 21HBQ582 ;  00-399227G , Lot Number 21KBJ142 ;  00-399227G , Lot Number 21LBA848 ;  00-399227G , Lot Number 19ABX389 ;  00-399227G , Lot Number 22OBD945 ;  00-399227G , Lot Number 19FBF786 ;  00-399227G , Lot Number 19FBV846 ;  00-399227G , Lot Number 22HBG087 ;  00-399227G , Lot Number 19HBD311 ;  00-399227G , Lot Number 22JBP132 ;  00-399227G , Lot Number 19IBR526 ;  00-399227G , Lot Number 19KBL802 ;  00-399227G , Lot Number 23CBG549 ;  00-399227G , Lot Number 19LBY409 ;  00-399227G , Lot Number 20ABD605 ;  00-399227G , Lot Number 23FBQ709 ;  00-399227G , Lot Number 20CBV379 ;  00-399227G , Lot Number 23HBW465 ;  00-399227G , Lot Number 20EBL397 ;  00-399227G , Lot Number 20GBW360 ;  00-399227G , Lot Number 20JBJ256 ;  00-399227G , Lot Number 20VBB916 ;  00-399227G , Lot Number 21ABG945 ;  00-399227G , Lot Number 21EBA473 ;  00-399607N, Lot Number 24BME638;  00-399607N , Lot Number 21FBQ697 ;  00-399607N , Lot Number 21HBF930 ;  00-399607N , Lot Number 21IBK326 ;  00-399607N , Lot Number 21IBK327 ;  00-399607N , Lot Number 22BBP057 ;  00-399607N , Lot Number 19BBE379 ;  00-399607N , Lot Number 19BBG294 ;  00-399607N , Lot Number 22DBE564 ;  00-399607N , Lot Number 19DBF156 ;  00-399607N , Lot Number 19EBD546 ;  00-399607N , Lot Number 22FBI051 ;  00-399607N , Lot Number 19EBQ718 ;  00-399607N , Lot Number 19FBU662 ;  00-399607N , Lot Number 19GBL581 ;  00-399607N , Lot Number 22HBZ204 ;  00-399607N , Lot Number 22JBJ129 ;  00-399607N , Lot Number 19IBH297 ;  00-399607N , Lot Number 19IBZ735 ;  00-399607N , Lot Number 19VBC702 ;  00-399607N , Lot Number 19VBG151 ;  00-399607N , Lot Number 23ABS680 ;  00-399607N , Lot Number 19KBR370 ;  00-399607N , Lot Number 19KBW839 ;  00-399607N , Lot Number 19LBK459 ;  00-399607N , Lot Number 23DBR467 ;  00-399607N , Lot Number 23FBG342 ;  00-399607N , Lot Number 20BBX536 ;  00-399607N , Lot Number 23HBC816 ;  00-399607N , Lot Number 20DBN717 ;  00-399607N , Lot Number 23IBG758 ;  00-399607N , Lot Number 20FBF254 ;  00-399607N , Lot Number 23KBM922 ;  00-399607N , Lot Number 20HBO924 ;  00-399607N , Lot Number 20JBH212 ;  00-399607N , Lot Number 20XBI689 ;  00-399607N , Lot Number 21CBU874 ;  00-399607N , Lot Number 21DBB347 ;  00-399607N , Lot Number 23LMG018 ;  00-400616J , Lot Number 21JBQ238 ;  00-400616J , Lot Number 21KBM208 ;  00-400616J , Lot Number 21LBQ198 ;  00-400616J , Lot Number 21LBQ199 ;  00-400616J , Lot Number 19ABC535 ;  00-400616J , Lot Number 19ABQ477 ;  00-400616J , Lot Number 19BBT275 ;  00-400616J , Lot Number 19EBJ953 ;  00-400616J , Lot Number 22FBX768 ;  00-400616J , Lot Number 19GBA150 ;  00-400616J , Lot Number 22IBJ517 ;  00-400616J , Lot Number 22JBS696 ;  00-400616J , Lot Number 19IBJ031 ;  00-400616J , Lot Number 22KBS745 ;  00-400616J , Lot Number 22LBL785 ;  00-400616J , Lot Number 19JBT508 ;  00-400616J , Lot Number 19LBA785 ;  00-400616J , Lot Number 23CBX354 ;  00-400616J , Lot Number 23EBW479 ;  00-400616J , Lot Number 20BBR220 ;  00-400616J , Lot Number 20EBO092 ;  00-400616J , Lot Number 23JBA018 ;  00-400616J , Lot Number 23KBO018 ;  00-400616J , Lot Number 23LBJ675 ;  00-400616J , Lot Number 20LBI288 ;  00-400616J , Lot Number 20LBJ402 ;  00-400616J , Lot Number 20XBC223 ;  00-400616J , Lot Number 21CBN764 ;  00-400616J , Lot Number 21CBT581 ;  00-400616J , Lot Number 21EBF051 ;  00-400830S , Lot Number 23IBE843 ;  00-400830S , Lot Number 23IBI196 ;  00-400830S , Lot Number 23JBL301 ;  00-400830S , Lot Number 23KBI335 ;  00-400830S , Lot Number 24ABE342 ;  00-400830S , Lot Number 19JDC900 ;  00-400830S , Lot Number 19KMB409 ;  00-400830S , Lot Number 19LMB845 ;  00-400830S , Lot Number 20AMA452 ;  00-400830S , Lot Number 20BMC093 ;  00-400830S , Lot Number 20CMC351 ;  00-400830S , Lot Number 20CMC443 ;  00-400830S , Lot Number 20GMB539 ;  00-400830S , Lot Number 20HMC006 ;  00-400830S , Lot Number 20LMA673 ;  00-400830S , Lot Number 20LME457 ;  00-400830S , Lot Number 21BME605 ;  00-400830S , Lot Number 21DMD032 ;  00-400830S , Lot Number 21FME404 ;  00-400830S , Lot Number 21HMB981 ;  00-400830S , Lot Number 21IMB345 ;  00-400830S , Lot Number 21JMA926 ;  00-400830S , Lot Number 21KMH647 ;  00-400830S , Lot Number 22BMB219 ;  00-400830S , Lot Number 22CMD635 ;  00-400830S , Lot Number 22DMB287 ;  00-400830S , Lot Number 22FMA468 ;  00-400830S , Lot Number 22GMG716 ;  00-400830S , Lot Number 22IMC098 ;  00-400830S , Lot Number 22KMD166 ;  00-400830S , Lot Number 23AME191 ;  00-400830S , Lot Number 23CMD960 ;  00-400830S , Lot Number 23DMH465 ;  00-400830S , Lot Number 23FMC224 ;  00-401585M , Lot Number 19ABR824 ;  00-401585M , Lot Number 19DBP669 ;  00-401585M , Lot Number 19FBI427 ;  00-401585M , Lot Number 19FBO698 ;  00-401585M , Lot Number 19IBH054 ;  00-401585M , Lot Number 19LBD645 ;  00-401585M , Lot Number 20BBB119 ;  00-401585M , Lot Number 23IBJ823 ;  00-401585M , Lot Number 23LBL663 ;  00-401585M , Lot Number 20FMA061 ;  00-401585M , Lot Number 20JMC537 ;  00-401585M , Lot Number 20KMC440 ;  00-401585M , Lot Number 20LMD216 ;  00-401585M , Lot Number 20LMD921 ;  00-401585M , Lot Number 21FMC730 ;  00-401585M , Lot Number 21HMC720 ;  00-401585M , Lot Number 21LMA689 ;  00-401585M , Lot Number 22AMB433 ;  00-401585M , Lot Number 22EMA952 ;  00-401585M , Lot Number 22FMF861 ;  00-401585M , Lot Number 22JMH077 ;  00-401585M , Lot Number 23BMH392 ;  00-401585M , Lot Number 23EMC343 ;  00-401585M , Lot Number 23FMF240 ;  00-401800F , Lot Number 23KBJ336 ;  00-401824Y , Lot Number 19ABA463 ;  00-401824Y , Lot Number 19BBM632 ;  00-401824Y , Lot Number 19DBF545 ;  00-401824Y , Lot Number 19EBP557 ;  00-401824Y , Lot Number 19QBC013 ;  00-401824Y , Lot Number 19GBO308 ;  00-401824Y , Lot Number 19IBN215 ;  00-401824Y , Lot Number 20ABS313 ;  00-401824Y , Lot Number 20OBA225 ;  00-401824Y , Lot Number 20DBT822 ;  00-401824Y , Lot Number 20GBO557 ;  00-401824Y , Lot Number 20JBK032 ;  00-401824Y , Lot Number 20KBN921 ;  00-401824Y , Lot Number 21ABI762 ;  00-401993N , Lot Number 21GBQ640 ;  00-401993N , Lot Number 21IBF580 ;  00-401993N , Lot Number 21JBU044 ;  00-401993N , Lot Number 21VBA791 ;  00-401993N , Lot Number 21VBB237 ;  00-401993N , Lot Number 22ABN204 ;  00-401993N , Lot Number 19ABA852 ;  00-401993N , Lot Number 22BBP800 ;  00-401993N , Lot Number 19BBK028 ;  00-401993N , Lot Number 22CBZ966 ;  00-401993N , Lot Number 19DBH070 ;  00-401993N , Lot Number 22EBI940 ;  00-401993N , Lot Number 19FBA602 ;  00-401993N , Lot Number 19HBU668 ;  00-401993N , Lot Number 19UBB094 ;  00-401993N , Lot Number 22LBF683 ;  00-401993N , Lot Number 19JBT421 ;  00-401993N , Lot Number 23BBR801 ;  00-401993N , Lot Number 23CBQ612 ;  00-401993N , Lot Number 20ABA347 ;  00-401993N , Lot Number 20ABB319 ;  00-401993N , Lot Number 23FBL707 ;  00-401993N , Lot Number 23GBJ048 ;  00-401993N , Lot Number 20DBJ587 ;  00-401993N , Lot Number 20EBG102 ;  00-401993N , Lot Number 20FBT276 ;  00-401993N , Lot Number 20GBP559 ;  00-401993N , Lot Number 20JBS101 ;  00-401993N , Lot Number 20LBD910 ;  00-401993N , Lot Number 21ABF837 ;  00-401993N , Lot Number 21CBG009 ;  00-401993N , Lot Number 21DBP970 ;  00-402001S , Lot Number 19ABA654 ;  00-402001S , Lot Number 19BBP621 ;  00-402001S , Lot Number 19QBC409 ;  00-402001S , Lot Number 19HBM341 ;  00-402001S , Lot Number 19JBT480 ;  00-402001S , Lot Number 19KBY244 ;  00-402001S , Lot Number 20DBL145 ;  00-402001S , Lot Number 20FBG027 ;  00-402001S , Lot Number 20FBS826 ;  00-402001S , Lot Number 20GBV471 ;  00-402001S , Lot Number 20XBF495 ;  00-402001S , Lot Number 21ABV063 ;  00-402001S , Lot Number 21BBK296 ;  00-402001S , Lot Number 21OBA437 ;  00-500502L , Lot Number 21FBQ822 ;  00-500502L , Lot Number 21GBG200 ;  00-500502L , Lot Number 21GBG201 ;  00-500502L , Lot Number 21IBE198 ;  00-500502L , Lot Number 21IBE206 ;  00-500502L , Lot Number 21JBW429 ;  00-500502L , Lot Number 21JBW430 ;  00-500502L , Lot Number 21KBE867 ;  00-500502L , Lot Number 21KBY362 ;  00-500502L , Lot Number 21KBY374 ;  00-500502L , Lot Number 19ABA085 ;  00-500502L , Lot Number 19ABI811 ;  00-500502L , Lot Number 22BBT378 ;  00-500502L , Lot Number 22BBT379 ;  00-500502L , Lot Number 19BBQ204 ;  00-500502L , Lot Number 19BBR402 ;  00-500502L , Lot Number 22CBX799 ;  00-500502L , Lot Number 19CBR070 ;  00-500502L , Lot Number 22EBA699 ;  00-500502L , Lot Number 22EBB201 ;  00-500502L , Lot Number 19DBP719 ;  00-500502L , Lot Number 19EBD843 ;  00-500502L , Lot Number 19EBH891 ;  00-500502L , Lot Number 19FBX379 ;  00-500502L , Lot Number 19GBV424 ;  00-500502L , Lot Number 22IBV010 ;  00-500502L , Lot Number 19HBV042 ;  00-500502L , Lot Number 19HBV396 ;  00-500502L , Lot Number 19HBZ613 ;  00-500502L , Lot Number 22JBO424 ;  00-500502L , Lot Number 22KBH252 ;  00-500502L , Lot Number 19JBB787 ;  00-500502L , Lot Number 19JBD275 ;  00-500502L , Lot Number 19VBE471 ;  00-500502L , Lot Number 23ABQ712 ;  00-500502L , Lot Number 19KBG190 ;  00-500502L , Lot Number 19KBR248 ;  00-500502L , Lot Number 23CBD195 ;  00-500502L , Lot Number 19LBD652 ;  00-500502L , Lot Number 19LBQ139 ;  00-500502L , Lot Number 23DBR409 ;  00-500502L , Lot Number 20BBP470 ;  00-500502L , Lot Number 20BBV384 ;  00-500502L , Lot Number 23FBL413 ;  00-500502L , Lot Number 20CBF052 ;  00-500502L , Lot Number 23GBD678 ;  00-500502L , Lot Number 20DBA982 ;  00-500502L , Lot Number 23HBK169 ;  00-500502L , Lot Number 20DBQ596 ;  00-500502L , Lot Number 20EBQ279 ;  00-500502L , Lot Number 20FBI444 ;  00-500502L , Lot Number 23JBL387 ;  00-500502L , Lot Number 20FBV201 ;  00-500502L , Lot Number 23KBG260 ;  00-500502L , Lot Number 20IBC568 ;  00-500502L , Lot Number 20IBI906 ;  00-500502L , Lot Number 20JBC018 ;  00-500502L , Lot Number 20JBG575 ;  00-500502L , Lot Number 20LBU874 ;  00-500502L , Lot Number 20XBG703 ;  00-500502L , Lot Number 20XBH347 ;  00-500502L , Lot Number 21ABB285 ;  00-500502L , Lot Number 21BBB576 ;  00-500502L , Lot Number 21BBL849 ;  00-500502L , Lot Number 21CBN124 ;  00-500502L , Lot Number 21DBB370 ;  00-500502L , Lot Number 21DBX360 ;  00-500502L , Lot Number 21FBC905 ;  00-500502L , Lot Number 21FBC906 ;  00-500502L , Lot Number 20KMB152 ;  00-500502L , Lot Number 22CME650 ;  00-500502L , Lot Number 22DMF206 ;  0M-CP31377N, Lot Number 19ABU893 ;  0M-CP31377N, Lot Number 19CBF596 ;  0M-CP31377O, Lot Number 19EBH370 ;  0M-CP31377O, Lot Number 19EBX273 ;  0M-CP31377O, Lot Number 19FBR559 ;  0M-CP31377O, Lot Number 19SBB303 ;  0M-CP31377O, Lot Number 19SBD998 ;  0M-CP31377P, Lot Number 19UBB815 ;  0M-CP31377P, Lot Number 19VBH564 ;  0M-CP31377P, Lot Number 20ABH401 ;  0M-CP31377P, Lot Number 20BBL193 ;  0M-CP31377P, Lot Number 20BBV662 ;  0M-CP31377P, Lot Number 20DMB022 ;  0M-CP31377P, Lot Number 20EMB450 ;  0M-CP31377P, Lot Number 20FMB428 ;  0M-CP31377P, Lot Number 20LMC347 ;  0M-CP31377P, Lot Number 21AMA757 ;  0M-CP31377P, Lot Number 21AMC275 ;  0M-CP31377P, Lot Number 21CMA650 ;  0M-CP31377P, Lot Number 21EME165 ;  0M-CP31377P, Lot Number 21FMF730 ;  0M-CP31377P, Lot Number 21HMC498 ;  0M-CP31377P, Lot Number 21JMB391 ;  0M-CP31377P, Lot Number 21KMG065 ;  0M-CP31377P, Lot Number 22CMH524 ;  0M-CP31377P, Lot Number 22DMI295 ;  0M-CP31377P, Lot Number 22DMI296 ;  0M-CP31377P, Lot Number 22DMI297 ;  0M-CP31377P, Lot Number 22EMB816 ; 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A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3019-2024&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-3019-2024&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-3019-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3019-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-3019-2024&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-3019-2024&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-3019-2024/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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        "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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          "item": {
            "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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          "item": {
            "Field": "Initiated",
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 CDS840343K , Lot Number 19IBH989 ;  CDS840343K , Lot Number 23BBP209 ;  CDS840343K , Lot Number 23BBP340 ;  CDS840343K , Lot Number 23CBV969 ;  CDS840343K , Lot Number 19LBU159 ;  CDS840343K , Lot Number 20ABZ962 ;  CDS840343K , Lot Number 20BBT763 ;  CDS840343K , Lot Number 23GBB119 ;  CDS840343K , Lot Number 23GBW141 ;  CDS840343K , Lot Number 20EBO730 ;  CDS840343K , Lot Number 23IBL698 ;  CDS840343K , Lot Number 23JBE434 ;  CDS840343K , Lot Number 23KBP732 ;  CDS840343K , Lot Number 20IBC382 ;  CDS840343K , Lot Number 20IBQ897 ;  CDS840343K , Lot Number 20JBR280 ;  CDS840343K , Lot Number 24CBA919 ;  CDS840343K , Lot Number 21ABI745 ;  CDS840343K , Lot Number 21BBJ321 ;  CDS840343K , Lot Number 21DBF273 ;  CDS840343K , Lot Number 21EBF601 ;  CDS840354N , Lot Number 19EBC693 ;  CDS840354N , Lot Number 19GBC532 ;  CDS840354O , Lot Number 19HBN051 ;  CDS840354O , Lot Number 19KBB920 ;  CDS840354O , Lot Number 19LBQ515 ;  CDS840354P , Lot Number 21FBP633 ;  CDS840354P , Lot Number 21GBV725 ;  CDS840354P , Lot Number 21IBA006 ;  CDS840354P , Lot Number 21IBA007 ;  CDS840354P , Lot Number 21KBO456 ;  CDS840354P , Lot Number 22ABY131 ;  CDS840354P , Lot Number 20CBG521 ;  CDS840354P , Lot Number 20DBP928 ;  CDS840354P , Lot Number 20GBP278 ;  CDS840354P , Lot Number 20HBU135 ;  CDS840354P , Lot Number 20LBA007 ;  CDS840354P , Lot Number 21DBE093 ;  CDS840354P , Lot Number 22FMG222 ;  CDS840354P , Lot Number 22FMG225 ;  CDS840354Q , Lot Number 22HMG262 ;  CDS840354Q , Lot Number 22IMB557 ;  CDS840354Q , Lot Number 22LMI106 ;  CDS840354Q , Lot Number 23CME942 ;  CDS840354Q , Lot Number 23CMF221 ;  CDS840354Q , Lot Number 23EMK143 ;  CDS840368L , Lot Number 19ABJ865 ;  CDS840368L , Lot Number 19DBI529 ;  CDS840368L , Lot Number 19RBA316 ;  CDS840368L , Lot Number 19HBH361 ;  CDS840368L , Lot Number 19JBJ645 ;  CDS840368L , Lot Number 19KBB870 ;  CDS840368L , Lot Number 19KBO528 ;  CDS840368L , Lot Number 20BBB586 ;  CDS840368L , Lot Number 20CBF697 ;  CDS840368L , Lot Number 20EBC255 ;  CDS840368L , Lot Number 20FBR638 ;  CDS840368L , Lot Number 20HBG896 ;  CDS840368L , Lot Number 20IBN708 ;  CDS840368L , Lot Number 20KBK052 ;  CDS840379L , Lot Number 19ABX922 ;  CDS840453C , Lot Number 19BBF379 ;  CDS840453C , Lot Number 19CBR365 ;  CDS840453C , Lot Number 19DBD836 ;  CDS840453C , Lot Number 19DBY533 ;  CDS840453C , Lot Number 19FBX606 ;  CDS840453C , Lot Number 19TBB345 ;  CDS840453C , Lot Number 19IBZ494 ;  CDS840453C , Lot Number 19LBY088 ;  CDS840453C , Lot Number 20BBW909 ;  CDS840453C , Lot Number 20HBF103 ;  CDS840453C , Lot Number 20HBT185 ;  CDS840453C , Lot Number 20JBD511 ;  CDS840453C , Lot Number 21ABH722 ;  CDS840459N , Lot Number 19ABQ283 ;  CDS840459N , Lot Number 19BBI845 ;  CDS840459N , Lot Number 19CBG430 ;  CDS840459N , Lot Number 19DBY010 ;  CDS840459N , Lot Number 19FBR828 ;  CDS840459N , Lot Number 19TBC625 ;  CDS840459N , Lot Number 19IBE967 ;  CDS840459N , Lot Number 19JBU899 ;  CDS840459N , Lot Number 19KBB801 ;  CDS840468B , Lot Number 21HMC746 ;  CDS840468B , Lot Number 21HMF545 ;  CDS840468B , Lot Number 21IMA279 ;  CDS840468B , Lot Number 21IMB709 ;  CDS840468B , Lot Number 21JMF577 ;  CDS840468B , Lot Number 21KMD461 ;  CDS840468B , Lot Number 22BMB111 ;  CDS840468B , Lot Number 22DMD084 ;  CDS840468B , Lot Number 22KMD493 ;  CDS840468B , Lot Number 22LMA066 ;  CDS840468B , Lot Number 22LME436 ;  CDS840468B , Lot Number 22LME834 ;  CDS840468B , Lot Number 23EME854 ;  CDS840468B , Lot Number 23IMA273 ;  CDS840468B , Lot Number 23JMI185 ;  CDS840468B , Lot Number 19CKB125 ;  CDS840468B , Lot Number 19EKD809 ;  CDS840468B , Lot Number 19GKA710 ;  CDS840468B , Lot Number 19HKD258 ;  CDS840468B , Lot Number 19JKA541 ;  CDS840468B , Lot Number 20AKC093 ;  CDS840468B , Lot Number 20GKB425 ;  CDS840468B , Lot Number 20LKA068 ;  CDS840468B , Lot Number 21AKA582 ;  CDS840468B , Lot Number 21CKA462 ;  CDS840472N , Lot Number 19ABZ610 ;  CDS840472N , Lot Number 19CBS257 ;  CDS840472N , Lot Number 19DBA546 ;  CDS840472N , Lot Number 19DBN639 ;  CDS840472N , Lot Number 19EBT399 ;  CDS840472N , Lot Number 19FBJ752 ;  CDS840472N , Lot Number 19GBZ853 ;  CDS840472N , Lot Number 19IBH312 ;  CDS840472N , Lot Number 19JBC420 ;  CDS840490J , Lot Number 19BBO475 ;  CDS840490J , Lot Number 19EBN057 ;  CDS840490J , Lot Number",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}