{
  "@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-0509-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "MEDLINE procedure kits labeled as follows:    1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B;   2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C;   3) FEMORAL BLOCK TRAY, REF DYNJRA1739A;   4) FEMORAL BLOCK TRAY, REF DYNJRA1739B;   5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869;   6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035;   7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040;   8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O;   9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C;   10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B;   11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C;   12) CONTINUOUS EPIDURAL, REF PAIN1271A;   13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B;   14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317;   15) 20G CONT. EPID TRAY, REF PAIN1353B;   16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358;   17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361;   18) JHAC CONT EPIDURAL, REF PAIN1437A;   19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B;   20) EPIDURAL CATH KIT, REF PAIN1536A;   21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547;   22) EPIDURAL TRAY, REF PAIN1558;   23) CONTINUOUS EPIDURAL, REF PAIN1581A;   24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A;   25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B;   26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A;   27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636;   28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A;   29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A;   30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709;   31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A;   32) CONTINUOUS EPIDURAL, REF PAIN1766A;   33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806;   34) EPIDURAL TRAY IMF 103130, REF PAIN1807;   35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816;   36) CONTINUOUS EPIDURAL, REF PAIN1844;   37) CSE TRAY, REF PAIN1845;   38) BWH L&D EPIDURAL KIT, REF PAIN1846;   39) 17G CONT. EPI - MRI SAFE, REF PAIN1854;   40) 17G L&D CONT. EPIDURAL, REF PAIN1855;   41) CONTINUOUS/CSE TRAY, REF PAIN1856;   42) CONTINUOUS/CSE TRAY, REF PAIN1856A;   43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864;   44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A;   45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878;   46) CSE TRAY, REF PAIN1885;   47) TEAM HEALTH EPIDURAL, REF PAIN1887;   48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888;   49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890;   50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892;   51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893;   52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894;   53) CSE TRAY, REF PAIN1898;   54) CSE TRAY, REF PAIN1904;   55) 17/25G CSE TRAY, REF PAIN1919;   56) CSE TRAY, REF PAIN1920;   57) 17/25G CSE TRAY, REF PAIN1937;   58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940;   59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958;   60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967;   61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014;   62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025;   63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026;   64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028;   65) 17G CONT EPIDURAL NYLON, REF PAIN9030;   66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031;   67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034;   68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035;   69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036;   70) REINIF 19G EPI CATH S STERILE, REF REPICATH19;   71) CONT. EPIDURAL TRAY, REF SAMPA0105;   72) EPIDURAL CATH PACK, REF SAMPA0106;   73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110;   74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111",
  "description": "FDA recall Z-0509-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE procedure kits labeled as follows:    1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B;   2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C;   3) FEMORAL BLOCK TRAY, REF DYNJRA1739A;   4) FEMORAL BLOCK TRAY, REF DYNJRA1739B;   5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869;   6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035;   7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040;   8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O;   9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C;   10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B;   11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C;   12) CONTINUOUS EPIDURAL, REF PAIN1271A;   13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B;   14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317;   15) 20G CONT. EPID TRAY, REF PAIN1353B;   16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358;   17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361;   18) JHAC CONT EPIDURAL, REF PAIN1437A;   19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B;   20) EPIDURAL CATH KIT, REF PAIN1536A;   21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547;   22) EPIDURAL TRAY, REF PAIN1558;   23) CONTINUOUS EPIDURAL, REF PAIN1581A;   24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A;   25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B;   26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A;   27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636;   28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A;   29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A;   30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709;   31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A;   32) CONTINUOUS EPIDURAL, REF PAIN1766A;   33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806;   34) EPIDURAL TRAY IMF 103130, REF PAIN1807;   35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816;   36) CONTINUOUS EPIDURAL, REF PAIN1844;   37) CSE TRAY, REF PAIN1845;   38) BWH L&D EPIDURAL KIT, REF PAIN1846;   39) 17G CONT. EPI - MRI SAFE, REF PAIN1854;   40) 17G L&D CONT. EPIDURAL, REF PAIN1855;   41) CONTINUOUS/CSE TRAY, REF PAIN1856;   42) CONTINUOUS/CSE TRAY, REF PAIN1856A;   43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864;   44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A;   45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878;   46) CSE TRAY, REF PAIN1885;   47) TEAM HEALTH EPIDURAL, REF PAIN1887;   48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888;   49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890;   50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892;   51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893;   52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894;   53) CSE TRAY, REF PAIN1898;   54) CSE TRAY, REF PAIN1904;   55) 17/25G CSE TRAY, REF PAIN1919;   56) CSE TRAY, REF PAIN1920;   57) 17/25G CSE TRAY, REF PAIN1937;   58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940;   59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958;   60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967;   61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014;   62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025;   63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026;   64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028;   65) 17G CONT EPIDURAL NYLON, REF PAIN9030;   66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031;   67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034;   68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035;   69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036;   70) REINIF 19G EPI CATH S STERILE, REF REPICATH19;   71) CONT. EPIDURAL TRAY, REF SAMPA0105;   72) EPIDURAL CATH PACK, REF SAMPA0106;   73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110;   74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111 (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-0509-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE procedure kits labeled as follows:    1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B;   2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C;   3) FEMORAL BLOCK TRAY, REF DYNJRA1739A;   4) FEMORAL BLOCK TRAY, REF DYNJRA1739B;   5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869;   6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035;   7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040;   8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O;   9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C;   10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B;   11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C;   12) CONTINUOUS EPIDURAL, REF PAIN1271A;   13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B;   14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317;   15) 20G CONT. EPID TRAY, REF PAIN1353B;   16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358;   17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361;   18) JHAC CONT EPIDURAL, REF PAIN1437A;   19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B;   20) EPIDURAL CATH KIT, REF PAIN1536A;   21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547;   22) EPIDURAL TRAY, REF PAIN1558;   23) CONTINUOUS EPIDURAL, REF PAIN1581A;   24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A;   25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B;   26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A;   27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636;   28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A;   29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A;   30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709;   31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A;   32) CONTINUOUS EPIDURAL, REF PAIN1766A;   33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806;   34) EPIDURAL TRAY IMF 103130, REF PAIN1807;   35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816;   36) CONTINUOUS EPIDURAL, REF PAIN1844;   37) CSE TRAY, REF PAIN1845;   38) BWH L&D EPIDURAL KIT, REF PAIN1846;   39) 17G CONT. EPI - MRI SAFE, REF PAIN1854;   40) 17G L&D CONT. EPIDURAL, REF PAIN1855;   41) CONTINUOUS/CSE TRAY, REF PAIN1856;   42) CONTINUOUS/CSE TRAY, REF PAIN1856A;   43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864;   44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A;   45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878;   46) CSE TRAY, REF PAIN1885;   47) TEAM HEALTH EPIDURAL, REF PAIN1887;   48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888;   49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890;   50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892;   51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893;   52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894;   53) CSE TRAY, REF PAIN1898;   54) CSE TRAY, REF PAIN1904;   55) 17/25G CSE TRAY, REF PAIN1919;   56) CSE TRAY, REF PAIN1920;   57) 17/25G CSE TRAY, REF PAIN1937;   58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940;   59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958;   60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967;   61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014;   62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025;   63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026;   64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028;   65) 17G CONT EPIDURAL NYLON, REF PAIN9030;   66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031;   67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034;   68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035;   69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036;   70) REINIF 19G EPI CATH S STERILE, REF REPICATH19;   71) CONT. EPIDURAL TRAY, REF SAMPA0105;   72) EPIDURAL CATH PACK, REF SAMPA0106;   73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110;   74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0509-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0509-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE procedure kits labeled as follows:    1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B;   2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C;   3) FEMORAL BLOCK TRAY, REF DYNJRA1739A;   4) FEMORAL BLOCK TRAY, REF DYNJRA1739B;   5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869;   6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035;   7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040;   8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O;   9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C;   10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B;   11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C;   12) CONTINUOUS EPIDURAL, REF PAIN1271A;   13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B;   14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317;   15) 20G CONT. EPID TRAY, REF PAIN1353B;   16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358;   17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361;   18) JHAC CONT EPIDURAL, REF PAIN1437A;   19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B;   20) EPIDURAL CATH KIT, REF PAIN1536A;   21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547;   22) EPIDURAL TRAY, REF PAIN1558;   23) CONTINUOUS EPIDURAL, REF PAIN1581A;   24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A;   25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B;   26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A;   27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636;   28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A;   29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A;   30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709;   31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A;   32) CONTINUOUS EPIDURAL, REF PAIN1766A;   33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806;   34) EPIDURAL TRAY IMF 103130, REF PAIN1807;   35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816;   36) CONTINUOUS EPIDURAL, REF PAIN1844;   37) CSE TRAY, REF PAIN1845;   38) BWH L&D EPIDURAL KIT, REF PAIN1846;   39) 17G CONT. EPI - MRI SAFE, REF PAIN1854;   40) 17G L&D CONT. EPIDURAL, REF PAIN1855;   41) CONTINUOUS/CSE TRAY, REF PAIN1856;   42) CONTINUOUS/CSE TRAY, REF PAIN1856A;   43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864;   44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A;   45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878;   46) CSE TRAY, REF PAIN1885;   47) TEAM HEALTH EPIDURAL, REF PAIN1887;   48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888;   49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890;   50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892;   51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893;   52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894;   53) CSE TRAY, REF PAIN1898;   54) CSE TRAY, REF PAIN1904;   55) 17/25G CSE TRAY, REF PAIN1919;   56) CSE TRAY, REF PAIN1920;   57) 17/25G CSE TRAY, REF PAIN1937;   58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940;   59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958;   60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967;   61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014;   62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025;   63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026;   64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028;   65) 17G CONT EPIDURAL NYLON, REF PAIN9030;   66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031;   67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034;   68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035;   69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036;   70) REINIF 19G EPI CATH S STERILE, REF REPICATH19;   71) CONT. EPIDURAL TRAY, REF SAMPA0105;   72) EPIDURAL CATH PACK, REF SAMPA0106;   73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110;   74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111",
      "text": "The FDA logged enforcement record Z-0509-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE procedure kits labeled as follows:    1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B;   2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C;   3) FEMORAL BLOCK TRAY, REF DYNJRA1739A;   4) FEMORAL BLOCK TRAY, REF DYNJRA1739B;   5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869;   6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035;   7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040;   8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O;   9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C;   10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B;   11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C;   12) CONTINUOUS EPIDURAL, REF PAIN1271A;   13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B;   14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317;   15) 20G CONT. EPID TRAY, REF PAIN1353B;   16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358;   17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361;   18) JHAC CONT EPIDURAL, REF PAIN1437A;   19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B;   20) EPIDURAL CATH KIT, REF PAIN1536A;   21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547;   22) EPIDURAL TRAY, REF PAIN1558;   23) CONTINUOUS EPIDURAL, REF PAIN1581A;   24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A;   25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B;   26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A;   27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636;   28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A;   29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A;   30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709;   31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A;   32) CONTINUOUS EPIDURAL, REF PAIN1766A;   33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806;   34) EPIDURAL TRAY IMF 103130, REF PAIN1807;   35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816;   36) CONTINUOUS EPIDURAL, REF PAIN1844;   37) CSE TRAY, REF PAIN1845;   38) BWH L&D EPIDURAL KIT, REF PAIN1846;   39) 17G CONT. EPI - MRI SAFE, REF PAIN1854;   40) 17G L&D CONT. EPIDURAL, REF PAIN1855;   41) CONTINUOUS/CSE TRAY, REF PAIN1856;   42) CONTINUOUS/CSE TRAY, REF PAIN1856A;   43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864;   44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A;   45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878;   46) CSE TRAY, REF PAIN1885;   47) TEAM HEALTH EPIDURAL, REF PAIN1887;   48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888;   49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890;   50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892;   51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893;   52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894;   53) CSE TRAY, REF PAIN1898;   54) CSE TRAY, REF PAIN1904;   55) 17/25G CSE TRAY, REF PAIN1919;   56) CSE TRAY, REF PAIN1920;   57) 17/25G CSE TRAY, REF PAIN1937;   58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940;   59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958;   60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967;   61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014;   62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025;   63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026;   64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028;   65) 17G CONT EPIDURAL NYLON, REF PAIN9030;   66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031;   67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034;   68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035;   69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036;   70) REINIF 19G EPI CATH S STERILE, REF REPICATH19;   71) CONT. EPIDURAL TRAY, REF SAMPA0105;   72) EPIDURAL CATH PACK, REF SAMPA0106;   73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110;   74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111 — reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-16. Affected lots/codes: Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers:  20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525;    2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers:  21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268;    3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers:  23CBE392;    4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers:  23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191;    5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers:  23CBE391;    6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers:  22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382;    7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers:  23CBO446, 23DBK742, 23HBG091, 23HBG092;    8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers:  22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420;    9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers:  22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253;    10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers:  23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430;    11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers:  23ELA637, 23GLA586, 23HLA616, 23JLB208;    12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers:  23BLA979;    13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers:  22KLA735, 23ALA157;   14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers:  22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167;   15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers:  20ELA452;   16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers:  22FLB088, 23CLA573;   17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers:  22FLA642, 22GLA243, 23ILA612, 23JLA051;   18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers:  22EBA985, 23ABO995, 23KBH798, 23KBR650;   19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers:  22LLB007, 23ALA593, 23BLA987;   20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers:  23CLA081;   21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers:  23BLB100, 23FLA069, 23JLA884;   22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers:  23BMH883, 23GMA342, 23GMC058, 23IMC928;   23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers:  23BLB024, 23CLA024, 23ELB140;   24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers:  23BLA078, 23FLA277;   25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers:  23JLB184;   26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers:  22KLA748, 23BLA153;   27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers:  22FLA297;   28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers:  23GLA589, 23HLA915, 23JLA225, 23KLA831;   29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers:  22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169;   30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers:  23CLA719;   31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers:  23ELA723, 23ILA927;   32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers:  23FLB123, 23GLA313;   33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers:  22ELA290, 22FLB111;   34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers:  22FLB112, 23DLA445;   35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers:  22GLA509, 22GLA531;   36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers:  23BLA981, 23ELB126, 23ILA404, 23ILB016;   37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers:  23ELA640;   38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers:  23DLA446;   39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers:  22JLB193, 22LLA402;   40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers:  22LLA455, 23CLA867;   41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers:  22JLB162, 22LLA409;   42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers:  23HLB303;   43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers:  22HLB077, 22LLA731, 23FLA012;   44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers:  23LLA277;   45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers:  23ALA348, 23ELA724;   46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers:  22LLA664, 23DLA281, 23ELA641;   47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers:  22KLA920;   48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers:  23BLA151, 23BLB105;   49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers:  23BLB106;   50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers:  23BLB026, 23ELB077, 23ILA928;   51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers:  23BLA283, 23GLA624, 23HLA803;   52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers:  23BLB107, 23ELA725, 23GLA370;   53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers:  23BLA284, 23BLA726;   54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers:  23ELB079, 23GLA947, 23HLA774;   55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers:  23CLA461, 23GLB137, 23HLA653, 23ILA462;   56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers:  23FLA827, 23HLA259;   57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers:  23ELB122;   58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers:  23ELB080;   59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers:  23GBV335, 23IBL615;   60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers:  23IDA109, 23KDB373;   61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers:  23JBS142;   62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers:  22FLB008, 22LLA741;   63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers:  23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295;   64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers:  22GLA287, 22ILA124, 23CLA410;   65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers:  22FLB009, 22HLB347, 22ILA078, 23CLA407;   66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers:  22GLA057, 23ALA831, 23ELA887, 23GLA871;   67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers:  23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377;   68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers:  23BBP889;   69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers:  23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472;   70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers:  22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971;   71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers:  21JLA580;   72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers:  21LBY057;   73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers:  22BLA107, 22CLA719, 22CLA850;   74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers:  22LLA665. 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-0509-2025&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-0509-2025&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-0509-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0509-2025 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-0509-2025&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-0509-2025&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-0509-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0509-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0509-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers:  20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525;    2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers:  21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268;    3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers:  23CBE392;    4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers:  23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191;    5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers:  23CBE391;    6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers:  22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382;    7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers:  23CBO446, 23DBK742, 23HBG091, 23HBG092;    8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers:  22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420;    9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers:  22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253;    10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers:  23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430;    11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers:  23ELA637, 23GLA586, 23HLA616, 23JLB208;    12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers:  23BLA979;    13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers:  22KLA735, 23ALA157;   14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers:  22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167;   15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers:  20ELA452;   16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers:  22FLB088, 23CLA573;   17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers:  22FLA642, 22GLA243, 23ILA612, 23JLA051;   18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers:  22EBA985, 23ABO995, 23KBH798, 23KBR650;   19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers:  22LLB007, 23ALA593, 23BLA987;   20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers:  23CLA081;   21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers:  23BLB100, 23FLA069, 23JLA884;   22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers:  23BMH883, 23GMA342, 23GMC058, 23IMC928;   23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers:  23BLB024, 23CLA024, 23ELB140;   24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers:  23BLA078, 23FLA277;   25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers:  23JLB184;   26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers:  22KLA748, 23BLA153;   27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers:  22FLA297;   28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers:  23GLA589, 23HLA915, 23JLA225, 23KLA831;   29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers:  22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169;   30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers:  23CLA719;   31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers:  23ELA723, 23ILA927;   32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers:  23FLB123, 23GLA313;   33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers:  22ELA290, 22FLB111;   34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers:  22FLB112, 23DLA445;   35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers:  22GLA509, 22GLA531;   36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers:  23BLA981, 23ELB126, 23ILA404, 23ILB016;   37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers:  23ELA640;   38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers:  23DLA446;   39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers:  22JLB193, 22LLA402;   40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers:  22LLA455, 23CLA867;   41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers:  22JLB162, 22LLA409;   42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers:  23HLB303;   43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers:  22HLB077, 22LLA731, 23FLA012;   44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers:  23LLA277;   45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers:  23ALA348, 23ELA724;   46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers:  22LLA664, 23DLA281, 23ELA641;   47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers:  22KLA920;   48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers:  23BLA151, 23BLB105;   49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers:  23BLB106;   50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers:  23BLB026, 23ELB077, 23ILA928;   51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers:  23BLA283, 23GLA624, 23HLA803;   52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers:  23BLB107, 23ELA725, 23GLA370;   53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers:  23BLA284, 23BLA726;   54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers:  23ELB079, 23GLA947, 23HLA774;   55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers:  23CLA461, 23GLB137, 23HLA653, 23ILA462;   56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers:  23FLA827, 23HLA259;   57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers:  23ELB122;   58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers:  23ELB080;   59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers:  23GBV335, 23IBL615;   60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers:  23IDA109, 23KDB373;   61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers:  23JBS142;   62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers:  22FLB008, 22LLA741;   63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers:  23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295;   64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers:  22GLA287, 22ILA124, 23CLA410;   65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers:  22FLB009, 22HLB347, 22ILA078, 23CLA407;   66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers:  22GLA057, 23ALA831, 23ELA887, 23GLA871;   67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers:  23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377;   68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers:  23BBP889;   69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers:  23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472;   70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers:  22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971;   71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers:  21JLA580;   72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers:  21LBY057;   73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers:  22BLA107, 22CLA719, 22CLA850;   74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers:  22LLA665",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide.  Bermuda, Canada, Panama, UAE, US Virgin Islands",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}