{
  "@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-3044-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:   1) PACK VAGINAL DELIVERY , Pack Number AM185B ;  2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;  3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;  4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ;  5) LABOR & DELIVERY CDS, Pack Number CDS830039AK;  6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ;  7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ;  8) LABOR & DELIVERY, Pack Number CDS830054P ;  9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ;  10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ;  11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ;  12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ;  13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ;  14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ;  15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ;  16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ;  17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ;  18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ;  19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ;  20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ;  21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ;  22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ;  23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ;  24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ;  25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ;  26) DELIVERY CDS, Pack Number CDS830199K ;  27) DELIVERY CDS, Pack Number CDS981282O ;  28) OB PROCEDURE-LF , Pack Number CDS981335B ;  29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ;  30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ;  31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ;  32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ;  33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ;  34) VAGINAL MAJOR , Pack Number CDS982689O ;  35) VAGINAL MAJOR , Pack Number CDS982689P ;  36) VAGINAL MAJOR , Pack Number CDS982689Q ;  37) VAGINAL MAJOR , Pack Number CDS982689R ;  38) DELIVERY PROCEDURE, Pack Number CDS982761F ;  39) DELIVERY PROCEDURE, Pack Number CDS982761G ;  40) DELIVERY PROCEDURE, Pack Number CDS982761I ;  41) DELIVERY PROCEDURE, Pack Number CDS982761J ;  42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ;  43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ;  44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ;  45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ;  46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ;  47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ;  48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ;  49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ;  50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ;  51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959;  52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ;  53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ;  54) LABOR & DELIVERY CDS, Pack Number CDS983116C ;  55) LABOR & DELIVERY CDS, Pack Number CDS983116D ;  56) LABOR & DELIVERY CDS, Pack Number CDS983116F ;  57) LABOR & DELIVERY CDS, Pack Number CDS983116G ;  58) LABOR & DELIVERY CDS, Pack Number CDS983116I ;  59) MINOR VAGINAL CDS , Pack Number CDS983119B ;  60) VAGINAL MINOR , Pack Number CDS983268J ;  61) VAGINAL MINOR , Pack Number CDS983268L ;  62) GYN VAGINAL CDS , Pack Number CDS983528J ;  63) ACH MAJOR VAGINAL , Pack Number CDS983641F ;  64) ACH MAJOR VAGINAL , Pack Number CDS983641G ;  65) VAG HYST CDS, Pack Number CDS983697F ;  66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ;  67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ;  68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ;  69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ;  70) OB/GYN CDS, Pack Number CDS984173G ;  71) OB GYN, Pack Number CDS984173I ;  72) GROTH VAGINAL CDS , Pack Number CDS984201P ;  73) GROTH VAGINAL CDS , Pack Number CDS984201Q ;  74) GROTH VAGINAL CDS , Pack Number CDS984201R ;  75) GROTH VAGINAL CDS , Pack Number CDS984201U ;  76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ;  77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ;  78) VAGINAL DELIVERY CDS, Pack",
  "description": "FDA recall Z-3044-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) PACK VAGINAL DELIVERY , Pack Number AM185B ;  2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;  3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;  4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ;  5) LABOR & DELIVERY CDS, Pack Number CDS830039AK;  6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ;  7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ;  8) LABOR & DELIVERY, Pack Number CDS830054P ;  9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ;  10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ;  11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ;  12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ;  13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ;  14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ;  15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ;  16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ;  17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ;  18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ;  19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ;  20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ;  21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ;  22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ;  23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ;  24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ;  25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ;  26) DELIVERY CDS, Pack Number CDS830199K ;  27) DELIVERY CDS, Pack Number CDS981282O ;  28) OB PROCEDURE-LF , Pack Number CDS981335B ;  29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ;  30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ;  31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ;  32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ;  33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ;  34) VAGINAL MAJOR , Pack Number CDS982689O ;  35) VAGINAL MAJOR , Pack Number CDS982689P ;  36) VAGINAL MAJOR , Pack Number CDS982689Q ;  37) VAGINAL MAJOR , Pack Number CDS982689R ;  38) DELIVERY PROCEDURE, Pack Number CDS982761F ;  39) DELIVERY PROCEDURE, Pack Number CDS982761G ;  40) DELIVERY PROCEDURE, Pack Number CDS982761I ;  41) DELIVERY PROCEDURE, Pack Number CDS982761J ;  42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ;  43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ;  44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ;  45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ;  46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ;  47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ;  48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ;  49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ;  50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ;  51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959;  52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ;  53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ;  54) LABOR & DELIVERY CDS, Pack Number CDS983116C ;  55) LABOR & DELIVERY CDS, Pack Number CDS983116D ;  56) LABOR & DELIVERY CDS, Pack Number CDS983116F ;  57) LABOR & DELIVERY CDS, Pack Number CDS983116G ;  58) LABOR & DELIVERY CDS, Pack Number CDS983116I ;  59) MINOR VAGINAL CDS , Pack Number CDS983119B ;  60) VAGINAL MINOR , Pack Number CDS983268J ;  61) VAGINAL MINOR , Pack Number CDS983268L ;  62) GYN VAGINAL CDS , Pack Number CDS983528J ;  63) ACH MAJOR VAGINAL , Pack Number CDS983641F ;  64) ACH MAJOR VAGINAL , Pack Number CDS983641G ;  65) VAG HYST CDS, Pack Number CDS983697F ;  66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ;  67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ;  68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ;  69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ;  70) OB/GYN CDS, Pack Number CDS984173G ;  71) OB GYN, Pack Number CDS984173I ;  72) GROTH VAGINAL CDS , Pack Number CDS984201P ;  73) GROTH VAGINAL CDS , Pack Number CDS984201Q ;  74) GROTH VAGINAL CDS , Pack Number CDS984201R ;  75) GROTH VAGINAL CDS , Pack Number CDS984201U ;  76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ;  77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ;  78) VAGINAL DELIVERY CDS, Pack (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-3044-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:   1) PACK VAGINAL DELIVERY , Pack Number AM185B ;  2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;  3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;  4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ;  5) LABOR & DELIVERY CDS, Pack Number CDS830039AK;  6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ;  7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ;  8) LABOR & DELIVERY, Pack Number CDS830054P ;  9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ;  10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ;  11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ;  12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ;  13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ;  14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ;  15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ;  16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ;  17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ;  18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ;  19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ;  20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ;  21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ;  22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ;  23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ;  24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ;  25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ;  26) DELIVERY CDS, Pack Number CDS830199K ;  27) DELIVERY CDS, Pack Number CDS981282O ;  28) OB PROCEDURE-LF , Pack Number CDS981335B ;  29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ;  30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ;  31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ;  32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ;  33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ;  34) VAGINAL MAJOR , Pack Number CDS982689O ;  35) VAGINAL MAJOR , Pack Number CDS982689P ;  36) VAGINAL MAJOR , Pack Number CDS982689Q ;  37) VAGINAL MAJOR , Pack Number CDS982689R ;  38) DELIVERY PROCEDURE, Pack Number CDS982761F ;  39) DELIVERY PROCEDURE, Pack Number CDS982761G ;  40) DELIVERY PROCEDURE, Pack Number CDS982761I ;  41) DELIVERY PROCEDURE, Pack Number CDS982761J ;  42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ;  43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ;  44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ;  45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ;  46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ;  47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ;  48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ;  49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ;  50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ;  51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959;  52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ;  53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ;  54) LABOR & DELIVERY CDS, Pack Number CDS983116C ;  55) LABOR & DELIVERY CDS, Pack Number CDS983116D ;  56) LABOR & DELIVERY CDS, Pack Number CDS983116F ;  57) LABOR & DELIVERY CDS, Pack Number CDS983116G ;  58) LABOR & DELIVERY CDS, Pack Number CDS983116I ;  59) MINOR VAGINAL CDS , Pack Number CDS983119B ;  60) VAGINAL MINOR , Pack Number CDS983268J ;  61) VAGINAL MINOR , Pack Number CDS983268L ;  62) GYN VAGINAL CDS , Pack Number CDS983528J ;  63) ACH MAJOR VAGINAL , Pack Number CDS983641F ;  64) ACH MAJOR VAGINAL , Pack Number CDS983641G ;  65) VAG HYST CDS, Pack Number CDS983697F ;  66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ;  67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ;  68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ;  69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ;  70) OB/GYN CDS, Pack Number CDS984173G ;  71) OB GYN, Pack Number CDS984173I ;  72) GROTH VAGINAL CDS , Pack Number CDS984201P ;  73) GROTH VAGINAL CDS , Pack Number CDS984201Q ;  74) GROTH VAGINAL CDS , Pack Number CDS984201R ;  75) GROTH VAGINAL CDS , Pack Number CDS984201U ;  76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ;  77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ;  78) VAGINAL DELIVERY CDS, Pack",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3044-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3044-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:   1) PACK VAGINAL DELIVERY , Pack Number AM185B ;  2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;  3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;  4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ;  5) LABOR & DELIVERY CDS, Pack Number CDS830039AK;  6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ;  7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ;  8) LABOR & DELIVERY, Pack Number CDS830054P ;  9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ;  10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ;  11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ;  12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ;  13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ;  14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ;  15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ;  16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ;  17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ;  18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ;  19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ;  20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ;  21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ;  22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ;  23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ;  24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ;  25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ;  26) DELIVERY CDS, Pack Number CDS830199K ;  27) DELIVERY CDS, Pack Number CDS981282O ;  28) OB PROCEDURE-LF , Pack Number CDS981335B ;  29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ;  30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ;  31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ;  32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ;  33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ;  34) VAGINAL MAJOR , Pack Number CDS982689O ;  35) VAGINAL MAJOR , Pack Number CDS982689P ;  36) VAGINAL MAJOR , Pack Number CDS982689Q ;  37) VAGINAL MAJOR , Pack Number CDS982689R ;  38) DELIVERY PROCEDURE, Pack Number CDS982761F ;  39) DELIVERY PROCEDURE, Pack Number CDS982761G ;  40) DELIVERY PROCEDURE, Pack Number CDS982761I ;  41) DELIVERY PROCEDURE, Pack Number CDS982761J ;  42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ;  43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ;  44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ;  45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ;  46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ;  47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ;  48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ;  49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ;  50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ;  51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959;  52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ;  53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ;  54) LABOR & DELIVERY CDS, Pack Number CDS983116C ;  55) LABOR & DELIVERY CDS, Pack Number CDS983116D ;  56) LABOR & DELIVERY CDS, Pack Number CDS983116F ;  57) LABOR & DELIVERY CDS, Pack Number CDS983116G ;  58) LABOR & DELIVERY CDS, Pack Number CDS983116I ;  59) MINOR VAGINAL CDS , Pack Number CDS983119B ;  60) VAGINAL MINOR , Pack Number CDS983268J ;  61) VAGINAL MINOR , Pack Number CDS983268L ;  62) GYN VAGINAL CDS , Pack Number CDS983528J ;  63) ACH MAJOR VAGINAL , Pack Number CDS983641F ;  64) ACH MAJOR VAGINAL , Pack Number CDS983641G ;  65) VAG HYST CDS, Pack Number CDS983697F ;  66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ;  67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ;  68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ;  69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ;  70) OB/GYN CDS, Pack Number CDS984173G ;  71) OB GYN, Pack Number CDS984173I ;  72) GROTH VAGINAL CDS , Pack Number CDS984201P ;  73) GROTH VAGINAL CDS , Pack Number CDS984201Q ;  74) GROTH VAGINAL CDS , Pack Number CDS984201R ;  75) GROTH VAGINAL CDS , Pack Number CDS984201U ;  76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ;  77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ;  78) VAGINAL DELIVERY CDS, Pack",
      "text": "The FDA logged enforcement record Z-3044-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:   1) PACK VAGINAL DELIVERY , Pack Number AM185B ;  2) LABOR & DELIVERY CDS, Pack Number CDS830039AF;  3) LABOR & DELIVERY CDS, Pack Number CDS830039AI;  4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ;  5) LABOR & DELIVERY CDS, Pack Number CDS830039AK;  6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ;  7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ;  8) LABOR & DELIVERY, Pack Number CDS830054P ;  9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ;  10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ;  11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ;  12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ;  13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ;  14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ;  15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ;  16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ;  17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ;  18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ;  19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ;  20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ;  21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ;  22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ;  23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ;  24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ;  25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ;  26) DELIVERY CDS, Pack Number CDS830199K ;  27) DELIVERY CDS, Pack Number CDS981282O ;  28) OB PROCEDURE-LF , Pack Number CDS981335B ;  29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ;  30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ;  31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ;  32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ;  33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ;  34) VAGINAL MAJOR , Pack Number CDS982689O ;  35) VAGINAL MAJOR , Pack Number CDS982689P ;  36) VAGINAL MAJOR , Pack Number CDS982689Q ;  37) VAGINAL MAJOR , Pack Number CDS982689R ;  38) DELIVERY PROCEDURE, Pack Number CDS982761F ;  39) DELIVERY PROCEDURE, Pack Number CDS982761G ;  40) DELIVERY PROCEDURE, Pack Number CDS982761I ;  41) DELIVERY PROCEDURE, Pack Number CDS982761J ;  42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ;  43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ;  44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ;  45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ;  46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ;  47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ;  48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ;  49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ;  50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ;  51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959;  52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ;  53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ;  54) LABOR & DELIVERY CDS, Pack Number CDS983116C ;  55) LABOR & DELIVERY CDS, Pack Number CDS983116D ;  56) LABOR & DELIVERY CDS, Pack Number CDS983116F ;  57) LABOR & DELIVERY CDS, Pack Number CDS983116G ;  58) LABOR & DELIVERY CDS, Pack Number CDS983116I ;  59) MINOR VAGINAL CDS , Pack Number CDS983119B ;  60) VAGINAL MINOR , Pack Number CDS983268J ;  61) VAGINAL MINOR , Pack Number CDS983268L ;  62) GYN VAGINAL CDS , Pack Number CDS983528J ;  63) ACH MAJOR VAGINAL , Pack Number CDS983641F ;  64) ACH MAJOR VAGINAL , Pack Number CDS983641G ;  65) VAG HYST CDS, Pack Number CDS983697F ;  66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ;  67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ;  68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ;  69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ;  70) OB/GYN CDS, Pack Number CDS984173G ;  71) OB GYN, Pack Number CDS984173I ;  72) GROTH VAGINAL CDS , Pack Number CDS984201P ;  73) GROTH VAGINAL CDS , Pack Number CDS984201Q ;  74) GROTH VAGINAL CDS , Pack Number CDS984201R ;  75) GROTH VAGINAL CDS , Pack Number CDS984201U ;  76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ;  77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ;  78) VAGINAL DELIVERY CDS, Pack — 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: AM185B , Lot Number 23BBS790 ;  AM185B , Lot Number 23IBT868 ;  AM185B , Lot Number 23JBW874 ;  AM185B , Lot Number 24ABQ730 ;  CDS830039AF, Lot Number 19GBO514 ;  CDS830039AF, Lot Number 19HBS937 ;  CDS830039AF, Lot Number 19JBM007 ;  CDS830039AF, Lot Number 19VBF341 ;  CDS830039AF, Lot Number 20ABQ286 ;  CDS830039AF, Lot Number 20BBR820 ;  CDS830039AF, Lot Number 20CBC115 ;  CDS830039AF, Lot Number 20EBC561 ;  CDS830039AF, Lot Number 20FBH160 ;  CDS830039AF, Lot Number 20GBG417 ;  CDS830039AF, Lot Number 20GBT038 ;  CDS830039AF, Lot Number 20JBA496 ;  CDS830039AF, Lot Number 20LBV774 ;  CDS830039AF, Lot Number 21ABJ105 ;  CDS830039AI, Lot Number 21HBA287 ;  CDS830039AI, Lot Number 21HBG893 ;  CDS830039AI, Lot Number 21IBJ983 ;  CDS830039AI, Lot Number 21LBQ697 ;  CDS830039AI, Lot Number 22ABA249 ;  CDS830039AI, Lot Number 22CBY819 ;  CDS830039AI, Lot Number 22OBB223 ;  CDS830039AI, Lot Number 21CBQ656 ;  CDS830039AI, Lot Number 21DBP447 ;  CDS830039AI, Lot Number 21FBH085 ;  CDS830039AJ, Lot Number 22DBI098 ;  CDS830039AJ, Lot Number 22EBN206 ;  CDS830039AJ, Lot Number 22FBC480 ;  CDS830039AJ, Lot Number 22FBD486 ;  CDS830039AJ, Lot Number 22FBT263 ;  CDS830039AJ, Lot Number 22FBW862 ;  CDS830039AK, Lot Number 22JBF161 ;  CDS830039AK, Lot Number 22KBQ120 ;  CDS830039AK, Lot Number 22LBC150 ;  CDS830039AK, Lot Number 23ABF855 ;  CDS830039AK, Lot Number 23CBH440 ;  CDS830039AK, Lot Number 23FBK921 ;  CDS830039AK, Lot Number 23FBK922 ;  CDS830039AK, Lot Number 23GBA194 ;  CDS830039AK, Lot Number 23HBO379 ;  CDS830039AK, Lot Number 23IBE023 ;  CDS830039AK, Lot Number 23JBL894 ;  CDS830039AK, Lot Number 23KBB125 ;  CDS830053G , Lot Number 21HBR110 ;  CDS830053G , Lot Number 21IBJ984 ;  CDS830053G , Lot Number 21KBT291 ;  CDS830053G , Lot Number 21KBW772 ;  CDS830053G , Lot Number 22BBK560 ;  CDS830053G , Lot Number 19ABC405 ;  CDS830053G , Lot Number 22BBQ057 ;  CDS830053G , Lot Number 19ABX756 ;  CDS830053G , Lot Number 22OBE801 ;  CDS830053G , Lot Number 19CBI663 ;  CDS830053G , Lot Number 22DBN943 ;  CDS830053G , Lot Number 19EBC550 ;  CDS830053G , Lot Number 22GBA870 ;  CDS830053G , Lot Number 19FBN913 ;  CDS830053G , Lot Number 19HBZ072 ;  CDS830053G , Lot Number 19IBI894 ;  CDS830053G , Lot Number 19IBP482 ;  CDS830053G , Lot Number 19JBP810 ;  CDS830053G , Lot Number 19LBL676 ;  CDS830053G , Lot Number 20ABL825 ;  CDS830053G , Lot Number 20CBV686 ;  CDS830053G , Lot Number 20FBN246 ;  CDS830053G , Lot Number 20GBP178 ;  CDS830053G , Lot Number 20IBC356 ;  CDS830053G , Lot Number 20IBG769 ;  CDS830053G , Lot Number 20LBV829 ;  CDS830053G , Lot Number 21ABM101 ;  CDS830053G , Lot Number 21BBA375 ;  CDS830053G , Lot Number 21CBA201 ;  CDS830053G , Lot Number 21CBB711 ;  CDS830053I , Lot Number 22GBB014 ;  CDS830053I , Lot Number 22IBJ347 ;  CDS830053I , Lot Number 22JBP418 ;  CDS830053I , Lot Number 22KBF644 ;  CDS830053I , Lot Number 22KBS025 ;  CDS830053I , Lot Number 23BBA669 ;  CDS830053I , Lot Number 23BBJ070 ;  CDS830053I , Lot Number 23BBN831 ;  CDS830053I , Lot Number 23EBD612 ;  CDS830053I , Lot Number 23FBA344 ;  CDS830053I , Lot Number 23GBD900 ;  CDS830053I , Lot Number 23IBJ528 ;  CDS830053I , Lot Number 23IBS206 ;  CDS830053I , Lot Number 23JBO100 ;  CDS830053I , Lot Number 23KBR822 ;  CDS830053I , Lot Number 24ABB121 ;  CDS830053I , Lot Number 24BBN779 ;  CDS830054P , Lot Number 21JBO031 ;  CDS830054P , Lot Number 21JBX762 ;  CDS830116T , Lot Number 21EMB670 ;  CDS830116T , Lot Number 21GMA024 ;  CDS830116T , Lot Number 21JMB604 ;  CDS830116T , Lot Number 21JMF853 ;  CDS830116T , Lot Number 21JMH576 ;  CDS830116T , Lot Number 21LMF690 ;  CDS830116T , Lot Number 22DMB054 ;  CDS830116T , Lot Number 22DMI608 ;  CDS830116T , Lot Number 22GMA496 ;  CDS830116T , Lot Number 22HMG373 ;  CDS830116T , Lot Number 22IME198 ;  CDS830116T , Lot Number 22JMD253 ;  CDS830116T , Lot Number 22KMF160 ;  CDS830116T , Lot Number 22KMG955 ;  CDS830116T , Lot Number 22LMD441 ;  CDS830116T , Lot Number 23BME252 ;  CDS830116T , Lot Number 23CME301 ;  CDS830116T , Lot Number 23EMD013 ;  CDS830116T , Lot Number 23GMD216 ;  CDS830116T , Lot Number 23IMB391 ;  CDS830116T , Lot Number 23JMA001 ;  CDS830116T , Lot Number 23JMB328 ;  CDS830116T , Lot Number 23KMC556 ;  CDS830116T , Lot Number 24AMG394 ;  CDS830116T , Lot Number 24BMA659 ;  CDS830116T , Lot Number 19AKA494 ;  CDS830116T , Lot Number 19BKC413 ;  CDS830116T , Lot Number 19CKD534 ;  CDS830116T , Lot Number 19FKA446 ;  CDS830116T , Lot Number 19GKB740 ;  CDS830116T , Lot Number 19HKC516 ;  CDS830116T , Lot Number 19IKB563 ;  CDS830116T , Lot Number 19JKB867 ;  CDS830116T , Lot Number 19LKB874 ;  CDS830116T , Lot Number 20BKB549 ;  CDS830116T , Lot Number 20EKA256 ;  CDS830116T , Lot Number 20EKB831 ;  CDS830116T , Lot Number 20FKB612 ;  CDS830116T , Lot Number 20HKB062 ;  CDS830116T , Lot Number 20IKB086 ;  CDS830116T , Lot Number 20LKB352 ;  CDS830116T , Lot Number 21BKA056 ;  CDS830116T , Lot Number 21CKA723 ;  CDS830118Q , Lot Number 19AKC562 ;  CDS830118Q , Lot Number 19BKB849 ;  CDS830118Q , Lot Number 19CKC028 ;  CDS830118Q , Lot Number 19DKC654 ;  CDS830118Q , Lot Number 19FKA351 ;  CDS830118R , Lot Number 19IKA570 ;  CDS830118R , Lot Number 19KKC104 ;  CDS830118R , Lot Number 20BKA872 ;  CDS830118S , Lot Number 21FMD347 ;  CDS830118S , Lot Number 21FMF056 ;  CDS830118S , Lot Number 21GMF219 ;  CDS830118S , Lot Number 21JME711 ;  CDS830118S , Lot Number 22BMA878 ;  CDS830118S , Lot Number 22CME725 ;  CDS830118S , Lot Number 22CMG970 ;  CDS830118S , Lot Number 22DMD957 ;  CDS830118S , Lot Number 22EME901 ;  CDS830118S , Lot Number 22HME575 ;  CDS830118S , Lot Number 22IMH126 ;  CDS830118S , Lot Number 22JMB663 ;  CDS830118S , Lot Number 22JMF150 ;  CDS830118S , Lot Number 20EKB812 ;  CDS830118S , Lot Number 20HKB275 ;  CDS830118S , Lot Number 20LKA346 ;  CDS830118S , Lot Number 20LKB137 ;  CDS830118S , Lot Number 21AKB216 ;  CDS830118S , Lot Number 21CKA306 ;  CDS830118S , Lot Number 21CKB178 ;  CDS830118S , Lot Number 21DKA367 ;  CDS830118T , Lot Number 22LMC177 ;  CDS830118T , Lot Number 23AMB057 ;  CDS830118T , Lot Number 23FMI895 ;  CDS830118T , Lot Number 23GMF443 ;  CDS830118T , Lot Number 23HMF250 ;  CDS830118T , Lot Number 23KMG894 ;  CDS830118T , Lot Number 23KMJ692 ;  CDS830118T , Lot Number 23LME667 ;  CDS830131J , Lot Number 19ABM872 ;  CDS830131J , Lot Number 19CBD005 ;  CDS830131J , Lot Number 19DBM651 ;  CDS830131J , Lot Number 19EBH293 ;  CDS830131J , Lot Number 19FBJ430 ;  CDS830131J , Lot Number 19RBC374 ;  CDS830131J , Lot Number 19HBV872 ;  CDS830131J , Lot Number 19JBJ533 ;  CDS830131J , Lot Number 19VBB798 ;  CDS830131J , Lot Number 19KBA662 ;  CDS830131K , Lot Number 21FBS279 ;  CDS830131K , Lot Number 21HBF889 ;  CDS830131K , Lot Number 21IBU364 ;  CDS830131K , Lot Number 21IBX809 ;  CDS830131K , Lot Number 21LBT876 ;  CDS830131K , Lot Number 22OBM263 ;  CDS830131K , Lot Number 22FBB172 ;  CDS830131K , Lot Number 20ABP025 ;  CDS830131K , Lot Number 20ABU699 ;  CDS830131K , Lot Number 20EBS035 ;  CDS830131K , Lot Number 20GBB065 ;  CDS830131K , Lot Number 20GBC231 ;  CDS830131K , Lot Number 20HBO225 ;  CDS830131K , Lot Number 21ABC255 ;  CDS830131K , Lot Number 21ABW317 ;  CDS830131K , Lot Number 21BBB750 ;  CDS830131K , Lot Number 21BBK116 ;  CDS830131L , Lot Number 22GBD116 ;  CDS830131L , Lot Number 22IBR912 ;  CDS830131L , Lot Number 22LBM244 ;  CDS830131L , Lot Number 22LBM698 ;  CDS830131L , Lot Number 23ABF942 ;  CDS830131L , Lot Number 23ABQ796 ;  CDS830131L , Lot Number 23DBE272 ;  CDS830131L , Lot Number 23DBM934 ;  CDS830131L , Lot Number 23EBN834 ;  CDS830131L , Lot Number 23FBF343 ;  CDS830131L , Lot Number 23IBJ058 ;  CDS830131L , Lot Number 23JBL895 ;  CDS830131L , Lot Number 23LBM365 ;  CDS830136S , Lot Number 20GBL464 ;  CDS830136S , Lot Number 20HBM600 ;  CDS830137O , Lot Number 21HBF463 ;  CDS830137O , Lot Number 21HBF464 ;  CDS830137O , Lot Number 21LBC576 ;  CDS830137O , Lot Number 21LBO564 ;  CDS830137O , Lot Number 19ABN116 ;  CDS830137O , Lot Number 19CBA050 ;  CDS830137O , Lot Number 22DBO876 ;  CDS830137O , Lot Number 22DBP352 ;  CDS830137O , Lot Number 19EBY135 ;  CDS830137O , Lot Number 19FBG825 ;  CDS830137O , Lot Number 22GBS220 ;  CDS830137O , Lot Number 19FBZ899 ;  CDS830137O , Lot Number 22HBN167 ;  CDS830137O , Lot Number 19IBB129 ;  CDS830137O , Lot Number 22KBH567 ;  CDS830137O , Lot Number 22KBU527 ;  CDS830137O , Lot Number 22LBG633 ;  CDS830137O , Lot Number 22LBG634 ;  CDS830137O , Lot Number 19JBW637 ;  CDS830137O , Lot Number 23ABH562 ;  CDS830137O , Lot Number 23BBR625 ;  CDS830137O , Lot Number 19LBH126 ;  CDS830137O , Lot Number 23CBR366 ;  CDS830137O , Lot Number 23EBI079 ;  CDS830137O , Lot Number 23GBH723 ;  CDS830137O , Lot Number 20DBB164 ;  CDS830137O , Lot Number 20DBB421 ;  CDS830137O , Lot Number 23HBM939 ;  CDS830137O , Lot Number 23IBF203 ;  CDS830137O , Lot Number 20EBR859 ;  CDS830137O , Lot Number 21ABK401 ;  CDS830137O , Lot Number 21ABL310 ;  CDS830137O , Lot Number 21BBO664 ;  CDS830137O , Lot Number 21EBI160 ;  CDS830137P , Lot Number 23JBY482 ;  CDS830137P , Lot Number 23KBH279 ;  CDS830137P , Lot Number 23KBM400 ;  CDS830137P , Lot Number 23LBT868 ;  CDS830137P , Lot Number 24ABX955 ;  CDS830140A , Lot Number 19AKB478 ;  CDS830140A , Lot Number 19CKC205 ;  CDS830140A , Lot Number 19EKB389 ;  CDS830140A , Lot Number 19FKC144 ;  CDS830140A , Lot Number 19HKC969 ;  CDS830140A , Lot Number 19JKA539 ;  CDS830140A , Lot Number 19KKB917 ;  CDS830140A , Lot Number 20AKA780 ;  CDS830140B , Lot Number 21FMF221 ;  CDS830140B , Lot Number 21HMG501 ;  CDS830140B , Lot Number 21JMB548 ;  CDS830140B , Lot Number 21KMF087 ;  CDS830140B , Lot Number 21LME158 ;  CDS830140B , Lot Number 21LMG072 ;  CDS830140B , Lot Number 22AMF900 ;  CDS830140B , Lot Number 22DMH110 ;  CDS830140B , Lot Number 22GMB325 ;  CDS830140B , Lot Number 22HMA893 ;  CDS830140B , Lot Number 22HMB582 ;  CDS830140B , Lot Number 23AMC002 ;  CDS830140B , Lot Number 23FMA953 ;  CDS830140B , Lot Number 23IMC561 ;  CDS830140B , Lot Number 23JMD151 ;  CDS830140B , Lot Number 23LMG886 ;  CDS830140B , Lot Number 20CKA191 ;  CDS830140B , Lot Number 20EKB854 ;  CDS830140B , Lot Number 20FKA370 ;  CDS830140B , Lot Number 20IKA974 ;  CDS830140B , Lot Number 20LKA970 ;  CDS830140B , Lot Number 21BKA446 ;  CDS830140B , Lot Number 21DKA052 ;  CDS830178K , Lot Number 19ABJ678 ;  CDS830178K , Lot Number 19BBN827 ;  CDS830178K , Lot Number 19CBE060 ;  CDS830178K , Lot Number 19CBL320 ;  CDS830178K , Lot Number 19EBB612 ;  CDS830178K , Lot Number 19FBY123 ;  CDS830178L , Lot Number 21HBD363 ;  CDS830178L , Lot Number 21HBI052 ;  CDS830178L , Lot Number 21IBG585 ;  CDS830178L , Lot Number 21IBO576 ;  CDS830178L , Lot Number 21KBW658 ;  CDS830178L , Lot Number 21WBA692 ;  CDS830178L , Lot Number 19IBB997 ;  CDS830178L , Lot Number 19JBG718 ;  CDS830178L , Lot Number 19VBH222 ;  CDS830178L , Lot Number 19KBH537 ;  CDS830178L , Lot Number 19LBQ608 ;  CDS830178L , Lot Number 20ABE276 ;  CDS830178L , Lot Number 20CBV581 ;  CDS830178L , Lot Number 20EBH246 ;  CDS830178L , Lot Number 20FBD482 ; 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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-3044-2024&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-3044-2024&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-3044-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3044-2024 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": {
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        "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-3044-2024&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-3044-2024&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-3044-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
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        "adjudged": false,
        "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.",
            "Status": "recorded"
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            "Field": "Initiated",
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 CDS983090C , Lot Number 22ABV322 ;  CDS983090C , Lot Number 22CBK077 ;  CDS983090C , Lot Number 22EBG688 ;  CDS983090C , Lot Number 19EBN515 ;  CDS983090C , Lot Number 22FBQ247 ;  CDS983090C , Lot Number 19FBW917 ;  CDS983090C , Lot Number 22HBR448 ;  CDS983090C , Lot Number 22IBT414 ;  CDS983090C , Lot Number 22IBU544 ;  CDS983090C , Lot Number 19TBD989 ;  CDS983090C , Lot Number 19IBZ067 ;  CDS983090C , Lot Number 23ABE729 ;  CDS983090C , Lot Number 23CBQ221 ;  CDS983090C , Lot Number 23FBA348 ;  CDS983090C , Lot Number 20CBF618 ;  CDS983090C , Lot Number 23HBG228 ;  CDS983090C , Lot Number 20EBD480 ;  CDS983090C , Lot Number 20FBJ393 ;  CDS983090C , Lot Number 20GBU849 ;  CDS983090C , Lot Number 20HBK185 ;  CDS983090C , Lot Number 24ABB066 ;  CDS983090C , Lot Number 20JBD425 ;  CDS983090C , Lot Number 24ABS328 ;  CDS983090C , Lot Number 20JBP937 ;  CDS983090C , Lot Number 20WBC024 ;  CDS983090C , Lot Number 20LBP515 ;  CDS983107G , Lot Number 22DBJ752 ;  CDS983107G , Lot Number 19HBK986 ;  CDS983107G , Lot Number 23DBT115 ;  CDS983107G , Lot Number 20DBF119 ;  CDS983107G , Lot Number 20DBQ082 ;  CDS983107G , Lot Number 20DBT422 ;  CDS983107G , Lot Number 20VBB217 ;  CDS983107G , Lot Number 20LBT251 ;  CDS983107G , Lot Number 20LBX549 ;  CDS983107G , Lot Number 21DBS568 ;  CDS983107G , Lot Number 21FBH208 ;  CDS983116C , Lot Number 19CBN492 ;  CDS983116C , Lot Number 19DBY599 ;  CDS983116C , Lot Number 19FBI734 ;  CDS983116D , Lot Number 19HBR288 ;  CDS983116D , Lot Number 19IBD309 ;  CDS983116D , Lot Number 19VBC040 ;  CDS983116D , Lot Number 19KBZ004 ;  CDS983116D , Lot Number 20ABI383 ;  CDS983116D , Lot Number 20DBJ070 ;  CDS983116D , Lot Number 20DBT261 ;  CDS983116D , Lot Number 20EBO938 ;  CDS983116D , Lot Number 20GBV788 ;  CDS983116D , Lot Number 20HBV904 ;  CDS983116D , Lot Number 20IBH994 ;  CDS983116D , Lot Number 20JBP623 ;  CDS983116F , Lot Number 21BBE442 ;  CDS983116F , Lot Number 21CBD966 ;  CDS983116F , Lot Number 21DBY210 ;  CDS983116G , Lot Number 21FBU367 ;  CDS983116G , Lot Number 21GBC749 ;  CDS983116G , Lot Number 21GBT671 ;  CDS983116G , Lot Number 21IBR139 ;  CDS983116G , Lot Number 21JBX808 ;  CDS983116G , Lot Number 22NBC735 ;  CDS983116I , Lot Number 22FBB086 ;  CDS983116I , Lot Number 22FBG084 ;  CDS983116I , Lot Number 22GBY312 ;  CDS983116I , Lot Number 22HBT608 ;  CDS983116I , Lot Number 22IBC541 ;  CDS983116I , Lot Number 22JBD234 ;  CDS983116I , Lot Number 22KBR575 ;  CDS983116I , Lot Number 22LBC612 ;  CDS983116I , Lot Number 23BBN532 ;  CDS983116I , Lot Number 23BBN817 ;  CDS983116I , Lot Number 23EBE315 ;  CDS983116I , Lot Number 23GBU340 ;  CDS983116I , Lot Number 23HBC598 ;  CDS983116I , Lot Number 23HBL138 ;  CDS983116I , Lot Number 23HBW939 ;  CDS983116I , Lot Number 23IBS641 ;  CDS983116I , Lot Number 23JBO011 ;  CDS983116I , Lot Number 23KBO183 ;  CDS983116I , Lot Number 23LBP362 ;  CDS983116I , Lot Number 24ABD307 ;  CDS983116I , Lot Number 24BBP100 ;  CDS983119B , Lot Number 19ABU256 ;  CDS983119B , Lot Number 19CBO665 ;  CDS983119B , Lot Number 19FBX882 ;  CDS983119B , Lot Number 19HBF324 ;  CDS983119B , Lot Number 19KBT628 ;  CDS983119B , Lot Number 19LBQ637 ;  CDS983119B , Lot Number 20ABU024 ;  CDS983119B , Lot Number 20DBN274 ;  CDS983119B , Lot Number 20GBG081 ;  CDS983119B , Lot Number 20KBU803 ;  CDS983119B , Lot Number 21BBE946 ;  CDS983268J , Lot Number 21HBT653 ;  CDS983268J , Lot Number 21JBF929 ;  CDS983268J , Lot Number 22BBG629 ;  CDS983268L , Lot Number 22KBF768 ;  CDS983268L , Lot Number 23ABM541 ;  CDS983268L , Lot Number 23CBP177 ;  CDS983268L , Lot Number 23EBA998 ;  CDS983268L , Lot Number 23FBC773 ;  CDS983268L , Lot Number 23GBW310 ;  CDS983268L , Lot Number 23IBN483 ;  CDS983268L , Lot Number 23JBT800 ;  CDS983528J , Lot Number 21GBT595 ;  CDS983528J , Lot Number 21IBR927 ;  CDS983528J , Lot Number 22ABK965 ;  CDS983528J , Lot Number 22BBM984 ;  CDS983528J , Lot Number 22BBY278 ;  CDS983528J , Lot Number 22DBC356 ;  CDS983528J , Lot Number 22EBJ563 ;  CDS983528J , Lot Number 22FBG648 ;  CDS983528J , Lot Number 20BBQ391 ;  CDS983528J , Lot Number 20DBH155 ;  CDS983528J , Lot Number 20GBQ346 ;  CDS983528J , Lot Number 20LBQ467 ;  CDS983528J , Lot Number 21ABW662 ;  CDS983528J , Lot Number 21DBA535 ;  CDS983528J , Lot Number 21DBV571 ;  CDS983641F , Lot Number 20GBL479 ;  CDS983641G , Lot Number 20IBG248 ;  CDS983641G , Lot Number 20IBM685 ;  CDS983697F , Lot Number 19BDB259 ;  CDS983697F , Lot Number 19EDC141 ;  CDS983697F , Lot Number 19GDB381 ;  CDS983697F , Lot Number 19IDA799 ;  CDS983697F , Lot Number 19LDA833 ;  CDS983697F , Lot Number 20BDB731 ;  CDS983697F , Lot Number 20CDA002 ;  CDS983697F , Lot Number 20CDA452 ;  CDS983919C , Lot Number 19ABY429 ;  CDS983919C , Lot Number 19DBH786 ;  CDS983919C , Lot Number 19GBH588 ;  CDS983919C , Lot Number 19IBY541 ;  CDS983919D , Lot Number 19LBV491 ;  CDS983919D , Lot Number 20CBC173 ;  CDS983919D , Lot Number 20FBC041 ;  CDS983919D , Lot Number 20HBM989 ;  CDS983919D , Lot Number 20IBO205 ;  CDS983919D , Lot Number 20LBC938 ;  CDS983919F , Lot Number 21IBJ216 ;  CDS983919F , Lot Number 21JBB507 ;  CDS983919F , Lot Number 22BBF388 ;  CDS983919F , Lot Number 22OBC138 ;  CDS983919F , Lot Number 22DBN605 ;  CDS983919F , Lot Number 22FBL720 ;  CDS983919F , Lot Number 22GBE742 ;  CDS983919F , Lot Number 22HBW180 ;  CDS983919F , Lot Number 22JBC939 ;  CDS983919F , Lot Number 22KBD696 ;  CDS983919F , Lot Number 22KBT274 ;  CDS983919F , Lot Number 22LBJ504 ;  CDS983919F , Lot Number 23ABR028 ;  CDS983919F , Lot Number 23CBN015 ;  CDS983919F , Lot Number 23EBJ331 ;  CDS983919F , Lot Number 23GBH722 ;  CDS983919F , Lot Number 23GBU990 ;  CDS983919F , Lot Number 23IBP584 ;  CDS983919F , Lot Number 23JBB081 ;  CDS983919F , Lot Number 23LBB140 ;  CDS983919F , Lot Number 23LBD714 ;  CDS983919F , Lot Number 21BBI374 ;  CDS983919F , Lot Number 21EBK922 ;  CDS983919G , Lot Number 24ABP274 ;  CDS984173G , Lot Number 22BBB883 ;  CDS984173G , Lot Number 22OBM455 ;  CDS984173G , Lot Number 22FBD564 ;  CDS984173G , Lot Number 22FBI504 ;  CDS984173G , Lot Number 22HBI938 ;  CDS984173G , Lot Number 22JBR312 ;  CDS984173G , Lot Number 22KBF548 ;  CDS984173G , Lot Number 23ABE846 ;  CDS984173G , Lot Number 23BBN932 ;  CDS984173G , Lot Number 23EBT372 ;  CDS984173I , Lot Number 23GBL953 ;  CDS984173I , Lot Number 23IBC443 ;  CDS984173I , Lot Number 23JBL114 ;  CDS984173I , Lot Number 23KBC018 ;  CDS984173I , Lot Number 23LBV726 ;  CDS984173I , Lot Number 24ABH477 ;  CDS984201P , Lot Number 19ABM987 ;  CDS984201P , Lot Number 19BBS363 ;  CDS984201P , Lot Number 19GBW300 ;  CDS984201P , Lot Number 19HBL316 ;  CDS984201P , Lot Number 19HBN663 ;  CDS984201Q , Lot Number 19KBO466 ;  CDS984201Q , Lot Number 19LBK667 ;  CDS984201Q , Lot Number 20EBE534 ;  CDS984201Q , Lot Number 20GBG373 ;  CDS984201R , Lot Number 20GBW206 ;  CDS984201U , Lot Number 22JBP421 ;  CDS984201U , Lot Number 22KBA301 ;  CDS984201U , Lot Number 22KBE485 ;  CDS984201U , Lot Number 22KBS048 ;  CDS984201U , Lot Number 23ABG935 ;  CDS984201U , Lot Number 23ABT861 ;  CDS984201U , Lot Number 23CBK362 ;  CDS984201U , Lot Number 23GBH493 ;  CDS984235F , Lot Number 22ABV568 ;  CDS984235F , Lot Number 22CBV466 ;  CDS984352C , Lot Number 19CBK505 ;  CDS984352C , Lot Number 19FBT822 ;  CDS984352C , Lot Number 19GBS253 ;  CDS984352D , Lot Number 19UBA519 ;  CDS984352D , Lot Number 20ABA002 ;  CDS984352D , Lot Number 20CBO944 ;  CDS984352D , Lot Number 20DBK803 ;  CDS984352D , Lot Number 20EBD796 ;  CDS984352D , Lot Number 20GBA431 ;  CDS984352D , Lot Number 20JBP449 ;  CDS984352D , Lot Number 20XBH025 ;  CDS984352D , Lot Number 21ABP168 ;  CDS984352D , Lot Number 21CBO734 ;  CDS984352F , Lot Number 21GBA695 ;  CDS984352F , Lot Number 21GBD919 ;  CDS984352F , Lot Number 21IBK076 ;  CDS984352F , Lot Number 21VBC570 ;  CDS984352F , Lot Number 22CBY935 ;  CDS984352F , Lot Number 22DBG650 ;  CDS984352F , Lot Number 22FBS964 ;  CDS984352F , Lot Number 22FBU839 ;  CDS984352F , Lot Number 22IBD688 ;  CDS984352F , Lot Number 22JBH729 ;  CDS984352F , Lot Number 23ABI688 ;  CDS984352F , Lot Number 23CBN754 ;  CDS984352F , Lot Number 23DBA328 ;  CDS984352F , Lot Number 23GBT975 ;  CDS984352F , Lot Number 23HBA667 ;  CDS984352F , Lot Number 23IBW399 ;  CDS984352F , Lot Number 23KBM707 ;  CDS984352F , Lot Number 24ABJ464 ;  CDS984352F , Lot Number 24BBI226 ;  CDS984388B , Lot Number 21FBR752 ;  CDS984388B , Lot Number 21HBV221 ;  CDS984388B , Lot Number 21LBS929 ;  CDS984388B , Lot Number 22BBC449 ;  CDS984388B , Lot Number 22OBJ910 ;  CDS984388B , Lot Number 19DBM393 ;  CDS984388B , Lot Number 22FBH583 ;  CDS984388B , Lot Number 19FBH719 ;  CDS984388B , Lot Number 22HBK579 ;  CDS984388B , Lot Number 19HBN080 ;  CDS984388B , Lot Number 22JBV990 ;  CDS984388B , Lot Number 19IBP489 ;  CDS984388B , Lot Number 23ABR496 ;  CDS984388B , Lot Number 23BBE467 ;  CDS984388B , Lot Number 19WBA872 ;  CDS984388B , Lot Number 23DBN637 ;  CDS984388B , Lot Number 20BBS575 ;  CDS984388B , Lot Number 23FBO322 ;  CDS984388B , Lot Number 23HBJ721 ;  CDS984388B , Lot Number 23IBK059 ;  CDS984388B , Lot Number 20FBH305 ;  CDS984388B , Lot Number 23JBW624 ;  CDS984388B , Lot Number 20GBU493 ;  CDS984388B , Lot Number 23LBL354 ;  CDS984388B , Lot Number 20IBP495 ;  CDS984388B , Lot Number 24BBK049 ;  CDS984388B , Lot Number 21ABQ639 ;  CDS984388B , Lot Number 21DBD007 ;  CDS984430D , Lot Number 19CBG702 ;  CDS984430F , Lot Number 21FBL041 ;  CDS9",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}