{
  "@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-2768-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Centurion procedure kits labeled as:   1) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020;  3) 6\" FEMORAL ARTERIAL  LINE KIT, Pack Number ART245B;  4) ADVANCED REPAIR KIT, Pack Number SUT15940;  5) ARTHROGRAM TRAY, Pack Number SPEC0004C;  6) ARTHROGRAM TRAY, Pack Number DYNDH1134;  7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;  8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;  9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500;  10) BIOPSY BASIC PACK, Pack Number P784604;  11) BIOPSY KIT, Pack Number DYNDA1466A;  12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;  13) BIOPSY TRAY, Pack Number BT1015;  14) BIOPSY TRAY, Pack Number DYNDH1273;  15) BIOPSY TRAY, Pack Number BT1060;  16) BIOPSY TRAY, Pack Number DYNDH1340;  17) BIOPSY TRAY, Pack Number P151659;  18) BIOPSY TRAY, Pack Number SPEC0292;  19) BIOPSY TRAY, Pack Number DYNDH1314A;  20) BIOPSY TRAY, Pack Number DYNDH1137C;  21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;  22) BIOPSY TRAY-LF, Pack Number SPEC4380;  23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115;  24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;  25) BREAST BIOPSY TRAY, Pack Number SPEC0130C;  26) CATHETER ON/OFF KIT, Pack Number DT5490B;  27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;  28) CHEST TUBE INSERTION TRAY, Pack Number CHT705;  29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;  30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A;  31) CIRCUMCISION TRAY, Pack Number CIT6260;  32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A;  34) CORE BIOPSY TRAY, Pack Number SPEC0083B;  35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;  36) CUSTOM BIOPSY TRAY, Pack Number MNS4815;  37) CUSTOM BX TRAY, Pack Number SPEC0071B;  38) DELIVERY ACCESSORY KIT, Pack Number MNS6496;  39) DIAGNOSTIC TRAY, Pack Number DYNDH1359;  40) E. R. LACERATION TRAY, Pack Number DYNDL1187A;  41) ER CHEST TUBE TRAY, Pack Number CHT1570A;  42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952;  43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421;  44) FINE LACERATION KIT, Pack Number SUT19360;  45) FINE LACERATION KIT, Pack Number SUT17215;  46) HH PACK BIOPSY, Pack Number BT345;  47) HSG TRAY, Pack Number DYNDH1453;  48) I&D TRAY, Pack Number ID2165;  49) INCISION & DRAINAGE TRAY, Pack Number ID2060;  50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;  51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;  52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;  53) LACERATION TRAY, Pack Number SUT20955;  54) LACERATION TRAY, Pack Number DYNDL1772;  55) LACERATION TRAY, Pack Number DYNDL1250C;  56) LACERATION TRAY, Pack Number DYNDL1887;  57) LACERATION TRAY, Pack Number SUT3780;  58) LACERATION TRAY, Pack Number DYNDL1774A;  59) LACERATION TRAY, Pack Number SUT18080;  60) LACERATION TRAY, Pack Number SUT21490;  61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;  62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;  63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;  64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;  65) LUMBAR PUNCTURE TRAY, Pack Number PT215;  66) LUMBAR TRAY, Pack Number SPEC0177;  67) LUMBAR TRAY, Pack Number DYNDH1540A;  68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;  69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;  70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A;  71) MYELOGRAM TRAY, Pack Number DYNJTS0516A;  72) MYELOGRAM TRAY, Pack Number DYNJTS0514;  73) MYELOGRAM TRAY, Pack Number DYNDH1531;  74) OB DELIVERY SET, Pack Number MNS3355;  75) OB DELIVERY TRAY, Pack Number MNS5575;  76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;  77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523;  78) PACEMAKER TRAY, Pack Number MNS12700;  79) PACEMAKER TRAY, Pack Number MNS12625;  80) PACEMAKER TRAY, Pack Number MNS12700A;  81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B;  82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;  83)",
  "description": "FDA recall Z-2768-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits labeled as:   1) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020;  3) 6\" FEMORAL ARTERIAL  LINE KIT, Pack Number ART245B;  4) ADVANCED REPAIR KIT, Pack Number SUT15940;  5) ARTHROGRAM TRAY, Pack Number SPEC0004C;  6) ARTHROGRAM TRAY, Pack Number DYNDH1134;  7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;  8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;  9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500;  10) BIOPSY BASIC PACK, Pack Number P784604;  11) BIOPSY KIT, Pack Number DYNDA1466A;  12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;  13) BIOPSY TRAY, Pack Number BT1015;  14) BIOPSY TRAY, Pack Number DYNDH1273;  15) BIOPSY TRAY, Pack Number BT1060;  16) BIOPSY TRAY, Pack Number DYNDH1340;  17) BIOPSY TRAY, Pack Number P151659;  18) BIOPSY TRAY, Pack Number SPEC0292;  19) BIOPSY TRAY, Pack Number DYNDH1314A;  20) BIOPSY TRAY, Pack Number DYNDH1137C;  21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;  22) BIOPSY TRAY-LF, Pack Number SPEC4380;  23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115;  24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;  25) BREAST BIOPSY TRAY, Pack Number SPEC0130C;  26) CATHETER ON/OFF KIT, Pack Number DT5490B;  27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;  28) CHEST TUBE INSERTION TRAY, Pack Number CHT705;  29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;  30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A;  31) CIRCUMCISION TRAY, Pack Number CIT6260;  32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A;  34) CORE BIOPSY TRAY, Pack Number SPEC0083B;  35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;  36) CUSTOM BIOPSY TRAY, Pack Number MNS4815;  37) CUSTOM BX TRAY, Pack Number SPEC0071B;  38) DELIVERY ACCESSORY KIT, Pack Number MNS6496;  39) DIAGNOSTIC TRAY, Pack Number DYNDH1359;  40) E. R. LACERATION TRAY, Pack Number DYNDL1187A;  41) ER CHEST TUBE TRAY, Pack Number CHT1570A;  42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952;  43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421;  44) FINE LACERATION KIT, Pack Number SUT19360;  45) FINE LACERATION KIT, Pack Number SUT17215;  46) HH PACK BIOPSY, Pack Number BT345;  47) HSG TRAY, Pack Number DYNDH1453;  48) I&D TRAY, Pack Number ID2165;  49) INCISION & DRAINAGE TRAY, Pack Number ID2060;  50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;  51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;  52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;  53) LACERATION TRAY, Pack Number SUT20955;  54) LACERATION TRAY, Pack Number DYNDL1772;  55) LACERATION TRAY, Pack Number DYNDL1250C;  56) LACERATION TRAY, Pack Number DYNDL1887;  57) LACERATION TRAY, Pack Number SUT3780;  58) LACERATION TRAY, Pack Number DYNDL1774A;  59) LACERATION TRAY, Pack Number SUT18080;  60) LACERATION TRAY, Pack Number SUT21490;  61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;  62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;  63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;  64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;  65) LUMBAR PUNCTURE TRAY, Pack Number PT215;  66) LUMBAR TRAY, Pack Number SPEC0177;  67) LUMBAR TRAY, Pack Number DYNDH1540A;  68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;  69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;  70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A;  71) MYELOGRAM TRAY, Pack Number DYNJTS0516A;  72) MYELOGRAM TRAY, Pack Number DYNJTS0514;  73) MYELOGRAM TRAY, Pack Number DYNDH1531;  74) OB DELIVERY SET, Pack Number MNS3355;  75) OB DELIVERY TRAY, Pack Number MNS5575;  76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;  77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523;  78) PACEMAKER TRAY, Pack Number MNS12700;  79) PACEMAKER TRAY, Pack Number MNS12625;  80) PACEMAKER TRAY, Pack Number MNS12700A;  81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B;  82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;  83) (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-2768-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centurion procedure kits labeled as:   1) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020;  3) 6\" FEMORAL ARTERIAL  LINE KIT, Pack Number ART245B;  4) ADVANCED REPAIR KIT, Pack Number SUT15940;  5) ARTHROGRAM TRAY, Pack Number SPEC0004C;  6) ARTHROGRAM TRAY, Pack Number DYNDH1134;  7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;  8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;  9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500;  10) BIOPSY BASIC PACK, Pack Number P784604;  11) BIOPSY KIT, Pack Number DYNDA1466A;  12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;  13) BIOPSY TRAY, Pack Number BT1015;  14) BIOPSY TRAY, Pack Number DYNDH1273;  15) BIOPSY TRAY, Pack Number BT1060;  16) BIOPSY TRAY, Pack Number DYNDH1340;  17) BIOPSY TRAY, Pack Number P151659;  18) BIOPSY TRAY, Pack Number SPEC0292;  19) BIOPSY TRAY, Pack Number DYNDH1314A;  20) BIOPSY TRAY, Pack Number DYNDH1137C;  21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;  22) BIOPSY TRAY-LF, Pack Number SPEC4380;  23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115;  24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;  25) BREAST BIOPSY TRAY, Pack Number SPEC0130C;  26) CATHETER ON/OFF KIT, Pack Number DT5490B;  27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;  28) CHEST TUBE INSERTION TRAY, Pack Number CHT705;  29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;  30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A;  31) CIRCUMCISION TRAY, Pack Number CIT6260;  32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A;  34) CORE BIOPSY TRAY, Pack Number SPEC0083B;  35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;  36) CUSTOM BIOPSY TRAY, Pack Number MNS4815;  37) CUSTOM BX TRAY, Pack Number SPEC0071B;  38) DELIVERY ACCESSORY KIT, Pack Number MNS6496;  39) DIAGNOSTIC TRAY, Pack Number DYNDH1359;  40) E. R. LACERATION TRAY, Pack Number DYNDL1187A;  41) ER CHEST TUBE TRAY, Pack Number CHT1570A;  42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952;  43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421;  44) FINE LACERATION KIT, Pack Number SUT19360;  45) FINE LACERATION KIT, Pack Number SUT17215;  46) HH PACK BIOPSY, Pack Number BT345;  47) HSG TRAY, Pack Number DYNDH1453;  48) I&D TRAY, Pack Number ID2165;  49) INCISION & DRAINAGE TRAY, Pack Number ID2060;  50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;  51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;  52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;  53) LACERATION TRAY, Pack Number SUT20955;  54) LACERATION TRAY, Pack Number DYNDL1772;  55) LACERATION TRAY, Pack Number DYNDL1250C;  56) LACERATION TRAY, Pack Number DYNDL1887;  57) LACERATION TRAY, Pack Number SUT3780;  58) LACERATION TRAY, Pack Number DYNDL1774A;  59) LACERATION TRAY, Pack Number SUT18080;  60) LACERATION TRAY, Pack Number SUT21490;  61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;  62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;  63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;  64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;  65) LUMBAR PUNCTURE TRAY, Pack Number PT215;  66) LUMBAR TRAY, Pack Number SPEC0177;  67) LUMBAR TRAY, Pack Number DYNDH1540A;  68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;  69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;  70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A;  71) MYELOGRAM TRAY, Pack Number DYNJTS0516A;  72) MYELOGRAM TRAY, Pack Number DYNJTS0514;  73) MYELOGRAM TRAY, Pack Number DYNDH1531;  74) OB DELIVERY SET, Pack Number MNS3355;  75) OB DELIVERY TRAY, Pack Number MNS5575;  76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;  77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523;  78) PACEMAKER TRAY, Pack Number MNS12700;  79) PACEMAKER TRAY, Pack Number MNS12625;  80) PACEMAKER TRAY, Pack Number MNS12700A;  81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B;  82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;  83)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2768-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2768-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits labeled as:   1) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020;  3) 6\" FEMORAL ARTERIAL  LINE KIT, Pack Number ART245B;  4) ADVANCED REPAIR KIT, Pack Number SUT15940;  5) ARTHROGRAM TRAY, Pack Number SPEC0004C;  6) ARTHROGRAM TRAY, Pack Number DYNDH1134;  7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;  8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;  9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500;  10) BIOPSY BASIC PACK, Pack Number P784604;  11) BIOPSY KIT, Pack Number DYNDA1466A;  12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;  13) BIOPSY TRAY, Pack Number BT1015;  14) BIOPSY TRAY, Pack Number DYNDH1273;  15) BIOPSY TRAY, Pack Number BT1060;  16) BIOPSY TRAY, Pack Number DYNDH1340;  17) BIOPSY TRAY, Pack Number P151659;  18) BIOPSY TRAY, Pack Number SPEC0292;  19) BIOPSY TRAY, Pack Number DYNDH1314A;  20) BIOPSY TRAY, Pack Number DYNDH1137C;  21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;  22) BIOPSY TRAY-LF, Pack Number SPEC4380;  23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115;  24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;  25) BREAST BIOPSY TRAY, Pack Number SPEC0130C;  26) CATHETER ON/OFF KIT, Pack Number DT5490B;  27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;  28) CHEST TUBE INSERTION TRAY, Pack Number CHT705;  29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;  30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A;  31) CIRCUMCISION TRAY, Pack Number CIT6260;  32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A;  34) CORE BIOPSY TRAY, Pack Number SPEC0083B;  35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;  36) CUSTOM BIOPSY TRAY, Pack Number MNS4815;  37) CUSTOM BX TRAY, Pack Number SPEC0071B;  38) DELIVERY ACCESSORY KIT, Pack Number MNS6496;  39) DIAGNOSTIC TRAY, Pack Number DYNDH1359;  40) E. R. LACERATION TRAY, Pack Number DYNDL1187A;  41) ER CHEST TUBE TRAY, Pack Number CHT1570A;  42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952;  43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421;  44) FINE LACERATION KIT, Pack Number SUT19360;  45) FINE LACERATION KIT, Pack Number SUT17215;  46) HH PACK BIOPSY, Pack Number BT345;  47) HSG TRAY, Pack Number DYNDH1453;  48) I&D TRAY, Pack Number ID2165;  49) INCISION & DRAINAGE TRAY, Pack Number ID2060;  50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;  51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;  52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;  53) LACERATION TRAY, Pack Number SUT20955;  54) LACERATION TRAY, Pack Number DYNDL1772;  55) LACERATION TRAY, Pack Number DYNDL1250C;  56) LACERATION TRAY, Pack Number DYNDL1887;  57) LACERATION TRAY, Pack Number SUT3780;  58) LACERATION TRAY, Pack Number DYNDL1774A;  59) LACERATION TRAY, Pack Number SUT18080;  60) LACERATION TRAY, Pack Number SUT21490;  61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;  62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;  63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;  64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;  65) LUMBAR PUNCTURE TRAY, Pack Number PT215;  66) LUMBAR TRAY, Pack Number SPEC0177;  67) LUMBAR TRAY, Pack Number DYNDH1540A;  68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;  69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;  70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A;  71) MYELOGRAM TRAY, Pack Number DYNJTS0516A;  72) MYELOGRAM TRAY, Pack Number DYNJTS0514;  73) MYELOGRAM TRAY, Pack Number DYNDH1531;  74) OB DELIVERY SET, Pack Number MNS3355;  75) OB DELIVERY TRAY, Pack Number MNS5575;  76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;  77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523;  78) PACEMAKER TRAY, Pack Number MNS12700;  79) PACEMAKER TRAY, Pack Number MNS12625;  80) PACEMAKER TRAY, Pack Number MNS12700A;  81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B;  82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;  83)",
      "text": "The FDA logged enforcement record Z-2768-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Centurion procedure kits labeled as:   1) 3\" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B;  2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020;  3) 6\" FEMORAL ARTERIAL  LINE KIT, Pack Number ART245B;  4) ADVANCED REPAIR KIT, Pack Number SUT15940;  5) ARTHROGRAM TRAY, Pack Number SPEC0004C;  6) ARTHROGRAM TRAY, Pack Number DYNDH1134;  7) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;  8) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;  9) AULTMAN HOSPITAL CHEST TUBE INSERTION TR, Pack Number CHT500;  10) BIOPSY BASIC PACK, Pack Number P784604;  11) BIOPSY KIT, Pack Number DYNDA1466A;  12) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;  13) BIOPSY TRAY, Pack Number BT1015;  14) BIOPSY TRAY, Pack Number DYNDH1273;  15) BIOPSY TRAY, Pack Number BT1060;  16) BIOPSY TRAY, Pack Number DYNDH1340;  17) BIOPSY TRAY, Pack Number P151659;  18) BIOPSY TRAY, Pack Number SPEC0292;  19) BIOPSY TRAY, Pack Number DYNDH1314A;  20) BIOPSY TRAY, Pack Number DYNDH1137C;  21) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;  22) BIOPSY TRAY-LF, Pack Number SPEC4380;  23) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115;  24) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;  25) BREAST BIOPSY TRAY, Pack Number SPEC0130C;  26) CATHETER ON/OFF KIT, Pack Number DT5490B;  27) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;  28) CHEST TUBE INSERTION TRAY, Pack Number CHT705;  29) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;  30) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A;  31) CIRCUMCISION TRAY, Pack Number CIT6260;  32) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A;  33) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A;  34) CORE BIOPSY TRAY, Pack Number SPEC0083B;  35) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;  36) CUSTOM BIOPSY TRAY, Pack Number MNS4815;  37) CUSTOM BX TRAY, Pack Number SPEC0071B;  38) DELIVERY ACCESSORY KIT, Pack Number MNS6496;  39) DIAGNOSTIC TRAY, Pack Number DYNDH1359;  40) E. R. LACERATION TRAY, Pack Number DYNDL1187A;  41) ER CHEST TUBE TRAY, Pack Number CHT1570A;  42) ER LACERATION TRAY C WEST, Pack Number DYNDL2952;  43) FACET BLOCK TRAY-AVERY MELVIN, Pack Number DYNJRA0421;  44) FINE LACERATION KIT, Pack Number SUT19360;  45) FINE LACERATION KIT, Pack Number SUT17215;  46) HH PACK BIOPSY, Pack Number BT345;  47) HSG TRAY, Pack Number DYNDH1453;  48) I&D TRAY, Pack Number ID2165;  49) INCISION & DRAINAGE TRAY, Pack Number ID2060;  50) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645;  51) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;  52) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;  53) LACERATION TRAY, Pack Number SUT20955;  54) LACERATION TRAY, Pack Number DYNDL1772;  55) LACERATION TRAY, Pack Number DYNDL1250C;  56) LACERATION TRAY, Pack Number DYNDL1887;  57) LACERATION TRAY, Pack Number SUT3780;  58) LACERATION TRAY, Pack Number DYNDL1774A;  59) LACERATION TRAY, Pack Number SUT18080;  60) LACERATION TRAY, Pack Number SUT21490;  61) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;  62) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;  63) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;  64) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;  65) LUMBAR PUNCTURE TRAY, Pack Number PT215;  66) LUMBAR TRAY, Pack Number SPEC0177;  67) LUMBAR TRAY, Pack Number DYNDH1540A;  68) MAMMOGRAPHY BIOPSY TRAY, Pack Number DYNDH1304A;  69) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324;  70) MYELO / ARTHRO TRAY, Pack Number DYNDH1332A;  71) MYELOGRAM TRAY, Pack Number DYNJTS0516A;  72) MYELOGRAM TRAY, Pack Number DYNJTS0514;  73) MYELOGRAM TRAY, Pack Number DYNDH1531;  74) OB DELIVERY SET, Pack Number MNS3355;  75) OB DELIVERY TRAY, Pack Number MNS5575;  76) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;  77) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523;  78) PACEMAKER TRAY, Pack Number MNS12700;  79) PACEMAKER TRAY, Pack Number MNS12625;  80) PACEMAKER TRAY, Pack Number MNS12700A;  81) PACK,CHALAZION SEY59CHCHA, Pack Number DYNDL1571B;  82) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;  83) — 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: ART240B, Lot Number 2023083190;  PICC0020, Lot Number 2023122290;  ART245B, Lot Number 2023020990;  ART245B, Lot Number 2023071090;  SUT15940, Lot Number 2021070290;  SUT15940, Lot Number 2022090190;  SUT15940, Lot Number 2022092690;  SPEC0004C, Lot Number 2019042990;  DYNDH1134, Lot Number 2020032050;  SPEC0400, Lot Number 2021120990;  SPEC0400, Lot Number 2022090190;  SPEC0400, Lot Number 2023050390;  PT220, Lot Number 2018082290;  PT220, Lot Number 2020040890;  PT220, Lot Number 2020051490;  PT220, Lot Number 2020061090;  PT220, Lot Number 2020071590;  PT220, Lot Number 2020122190;  PT220, Lot Number 2021040790;  PT220, Lot Number 2021050390;  PT220, Lot Number 2021080690;  PT220, Lot Number 2021082790;  PT220, Lot Number 2021100690;  PT220, Lot Number 2022082490;  PT220, Lot Number 2023030290;  PT220, Lot Number 2023110690;  PT220, Lot Number 2023122290;  PT220, Lot Number 2024031190;  CHT500, Lot Number 2021113090;  CHT500, Lot Number 2021121690;  CHT500, Lot Number 2022050390;  CHT500, Lot Number 2023060190;  CHT500, Lot Number 2023070390;  CHT500, Lot Number 2023092290;  P784604, Lot Number 2019081980;  DYNDA1466A, Lot Number 2022092690;  SUT20455, Lot Number 2018090690;  SUT20455, Lot Number 2019022590;  SUT20455, Lot Number 2019042990;  SUT20455, Lot Number 2019101690;  SUT20455, Lot Number 2019112590;  SUT20455, Lot Number 2020040690;  SUT20455, Lot Number 2021042190;  SUT20455, Lot Number 2021062590;  SUT20455, Lot Number 2021081090;  SUT20455, Lot Number 2022070590;  SUT20455, Lot Number 2023070590;  SUT20455, Lot Number 2023100590;  SUT20455, Lot Number 2023122990;  BT1015, Lot Number 2019013190;  DYNDH1273, Lot Number 2019080190;  BT1060, Lot Number 2019091090;  DYNDH1340, Lot Number 2019100190;  BT1060, Lot Number 2019103190;  P151659, Lot Number 2019112590;  DYNDH1340, Lot Number 2019121290;  SPEC0292, Lot Number 2020012290;  BT1015, Lot Number 2020082490;  BT1060, Lot Number 2020082890;  DYNDH1314A, Lot Number 2020100901;  BT1015, Lot Number 2020102990;  DYNDH1137C, Lot Number 2020102990;  BT1015, Lot Number 2021010590;  BT1015, Lot Number 2021032590;  BT1015, Lot Number 2021050390;  BT1015, Lot Number 2021070690;  BT1015, Lot Number 2021100490;  BT1015, Lot Number 2022021890;  BT1015, Lot Number 2022102490;  BT1015, Lot Number 2023013090;  BT1015, Lot Number 2023040490;  BT1015, Lot Number 2023060990;  DYNJTS0018A, Lot Number 2020010850;  DYNJTS0018A, Lot Number 2022050390;  SPEC4380, Lot Number 2021120990;  SPEC4380, Lot Number 2022032290;  SPEC4380, Lot Number 2022060890;  DYNDH1115, Lot Number 2019080190;  DYNJTS0214, Lot Number 2022051790;  DYNJTS0214, Lot Number 2023112890;  SPEC0130C, Lot Number 2020082490;  SPEC0130C, Lot Number 2021102790;  DT5490B, Lot Number 2022121490;  S5078BF09, Lot Number 2021031650;  CHT705, Lot Number 2019121290;  CHT705, Lot Number 2019121990;  CHT705, Lot Number 2020021890;  CHT705, Lot Number 2020040690;  CHT705, Lot Number 2021080690;  CHT1900, Lot Number 2022040590;  CHT705, Lot Number 2022092690;  CHT1900, Lot Number 2022110890;  DYNDA1432A, Lot Number 2019100190;  CIT6260, Lot Number 2020100901;  CIT6260, Lot Number 2022011190;  CIT6260, Lot Number 2022060890;  CIT6260, Lot Number 2022072290;  CIT6785A, Lot Number 2020081090;  CIT6785A, Lot Number 2021022390;  CIT6785A, Lot Number 2021032590;  DYNDA2213A, Lot Number 2019081980;  SPEC0083B, Lot Number 2022072190;  SPEC0083B, Lot Number 2023050390;  DYNJ05162, Lot Number 2022022390;  MNS4815, Lot Number 2021100590;  MNS4815, Lot Number 2021122890;  MNS4815, Lot Number 2023011390;  MNS4815, Lot Number 2023012090;  MNS4815, Lot Number 2023061590;  SPEC0071B, Lot Number 2019022590;  MNS6496, Lot Number 2019022590;  MNS6496, Lot Number 2023062990;  DYNDH1359, Lot Number 2019022590;  DYNDH1359, Lot Number 2019040290;  DYNDH1359, Lot Number 2019100190;  DYNDH1359, Lot Number 2020072290;  DYNDH1359, Lot Number 2020091490;  DYNDH1359, Lot Number 2021021990;  DYNDH1359, Lot Number 2021031290;  DYNDH1359, Lot Number 2021042290;  DYNDH1359, Lot Number 2021060490;  DYNDH1359, Lot Number 2021070690;  DYNDH1359, Lot Number 2022041890;  DYNDH1359, Lot Number 2022051790;  DYNDH1359, Lot Number 2022062990;  DYNDH1359, Lot Number 2023050390;  DYNDH1359, Lot Number 2023061990;  DYNDL1187A, Lot Number 2019121290;  CHT1570A, Lot Number 2021121690;  CHT1570A, Lot Number 2022032290;  CHT1570A, Lot Number 2023060190;  CHT1570A, Lot Number 2023070390;  DYNDL2952, Lot Number 2022030990;  DYNDL2952, Lot Number 2022062290;  DYNJRA0421, Lot Number 2019100190;  DYNJRA0421, Lot Number 2020010690;  SUT19360, Lot Number 2020070750;  SUT19360, Lot Number 2022062990;  SUT19360, Lot Number 2022091490;  SUT19360, Lot Number 2023030290;  SUT19360, Lot Number 2023062990;  SUT19360, Lot Number 2023081490;  SUT17215, Lot Number 2018110580;  SUT17215, Lot Number 2019030480;  SUT17215, Lot Number 2019081380;  SUT17215, Lot Number 2019123080;  SUT17215, Lot Number 2020091480;  SUT17215, Lot Number 2020102680;  SUT17215, Lot Number 2021011880;  SUT17215, Lot Number 2021032980;  SUT17215, Lot Number 2021060780;  SUT17215, Lot Number 2021102580;  BT345, Lot Number 2018071790;  BT345, Lot Number 2018080890;  DYNDH1453, Lot Number 2019080190;  ID2165, Lot Number 2020042090;  ID2165, Lot Number 2022101990;  ID2165, Lot Number 2022102690;  ID2165, Lot Number 2022111890;  ID2060, Lot Number 2022090190;  ID2060, Lot Number 2023010590;  ID2060, Lot Number 2023041490;  ID2060, Lot Number 2023080390;  ID2060, Lot Number 2023101190;  ID2060, Lot Number 2024030190;  DM645, Lot Number 2020091480;  MNS12150, Lot Number 2021031090;  MNS12150, Lot Number 2021092490;  MNS12150, Lot Number 2023071090;  DYNDH1297, Lot Number 2022051650;  SUT20955, Lot Number 2018082990;  SUT20955, Lot Number 2018100290;  DYNDL1772, Lot Number 2019022590;  SUT20955, Lot Number 2019042690;  DYNDL1250C, Lot Number 2019080190;  DYNDL1887, Lot Number 2019080190;  SUT3780, Lot Number 2019091790;  DYNDL1774A, Lot Number 2019091790;  SUT20955, Lot Number 2019110890;  SUT18080, Lot Number 2020010850;  SUT18080, Lot Number 2020032050;  SUT3780, Lot Number 2020032790;  SUT20955, Lot Number 2020041390;  SUT21490, Lot Number 2020042090;  SUT18080, Lot Number 2020063050;  SUT20955, Lot Number 2020070790;  SUT3780, Lot Number 2020082590;  SUT20955, Lot Number 2020101690;  SUT3780, Lot Number 2021020890;  SUT20955, Lot Number 2021031090;  SUT18080, Lot Number 2021031650;  SUT18080, Lot Number 2021052750;  SUT20955, Lot Number 2021070690;  SUT18080, Lot Number 2021081650;  SUT20955, Lot Number 2021082790;  SUT20955, Lot Number 2021102690;  SUT20955, Lot Number 2021113090;  SUT20955, Lot Number 2022030990;  SUT18080, Lot Number 2022042750;  SUT18080, Lot Number 2022051650;  SUT20955, Lot Number 2022060890;  SUT18080, Lot Number 2022070550;  SUT21490, Lot Number 2022092690;  SUT21490, Lot Number 2022110790;  SUT21490, Lot Number 2022111890;  SUT20955, Lot Number 2022121490;  SUT20955, Lot Number 2023042890;  SUT20955, Lot Number 2023112890;  DYNDH1406, Lot Number 2020010850;  DYNDH1406, Lot Number 2021120990;  DYNJRA0313B, Lot Number 2019042990;  DYNDH1321, Lot Number 2019042990;  DYNDH1321, Lot Number 2020010690;  SPEC0289, Lot Number 2020010690;  PT215, Lot Number 2023070390;  SPEC0177, Lot Number 2021102790;  DYNDH1540A, Lot Number 2022040590;  DYNDH1540A, Lot Number 2022101990;  DYNDH1304A, Lot Number 2020012290;  DYNDH1324, Lot Number 2020010850;  DYNDH1332A, Lot Number 2022111890;  DYNJTS0516A, Lot Number 2019112090;  DYNJTS0514, Lot Number 2021031650;  DYNDH1531, Lot Number 2021051390;  MNS3355, Lot Number 2021050390;  MNS5575, Lot Number 2019080190;  MNS5575, Lot Number 2020032390;  MNS5575, Lot Number 2020042090;  MNS5575, Lot Number 2020082890;  DYNDH1270, Lot Number 2019013190;  DYNDA2523, Lot Number 2022122190;  MNS12700, Lot Number 2020012290;  MNS12625, Lot Number 2020021790;  MNS12700, Lot Number 2020022490;  MNS12700A, Lot Number 2020081090;  MNS12625, Lot Number 2022072190;  MNS12700, Lot Number 2023012490;  MNS12700, Lot Number 2023060190;  DYNDL1571B, Lot Number 2019112590;  IVS3320, Lot Number 2020011090;  IVS3320, Lot Number 2020091490;  IVS3320, Lot Number 2021032590;  IVS3320, Lot Number 2021102790;  IVS3320, Lot Number 2022121490;  IVS3320, Lot Number 2023032990;  IVS3320, Lot Number 2023052590;  IVS3320, Lot Number 2023072590;  IVS3320, Lot Number 2023080490;  IVS3320, Lot Number 2023082190;  CVI4960, Lot Number 2023070590;  DYNDA1732A, Lot Number 2019101690;  DYNDC1960A, Lot Number 2023011390;  DYNDC2945, Lot Number 2020032390;  DYNDC2945, Lot Number 2020051490;  DYNDC2945, Lot Number 2021060790;  EBSI1241, Lot Number 2020021890;  EBSI1241, Lot Number 2021070290;  EBSI1241, Lot Number 2023060990;  EBSI1241, Lot Number 2023122290;  MNS11590, Lot Number 2021032590;  MNS11590, Lot Number 2021050390;  SPEC0251, Lot Number 2020010850;  DYNDC3274, Lot Number 2023013090;  SPEC0222A, Lot Number 2020070750;  SPEC0222A, Lot Number 2022032290;  SPEC0127, Lot Number 2019123080;  SPEC0149, Lot Number 2023011390;  DYNDA2725, Lot Number 2021102790;  DYNDC2859A, Lot Number 2021113090;  DYNDC2859A, Lot Number 2022101990;  DYNDC2859A, Lot Number 2022111890;  DYNDC2859A, Lot Number 2023012690;  DYNDC2859A, Lot Number 2023083190;  BT1095, Lot Number 2020010690;  DYNDA2495, Lot Number 2023092290;  SUT14745A, Lot Number 2022121390;  SUT14745A, Lot Number 2023032390;  SUT14745A, Lot Number 2023060190;  SUT14745A, Lot Number 2023092290;  SUT14745A, Lot Number 2023120690;  SUT14745A, Lot Number 2024020890;  MNS6465, Lot Number 2019040190;  MNS6465, Lot Number 2020010690;  MNS6465, Lot Number 2021051390;  MNS6465, Lot Number 2021081090;  MNS6465, Lot Number 2021090790;  MNS6465, Lot Number 2021100590;  MNS6465, Lot Number 2023060190;  SUT15695, Lot Number 2021070290;  SUT15695, Lot Number 2022011290;  SUT15695, Lot Number 2022022390;  SUT15695, Lot Number 2022122190;  SUT15695, Lot Number 2023050390;  SUT15695, Lot Number 2023083190;  SUT9975, Lot Number 2023042090;  SUT9975, Lot Number 2023051790;  SUT9975, Lot Number 2023062890;  SUT9975, Lot Number 2023100690;  SUT9790, Lot Number 2019121990;  SUT9790, Lot Number 2020011090;  SUT4020, Lot Number 2020041690;  SUT9790, Lot Number 2020061890;  SUT4020, Lot Number 2020091190;  SUT4020, Lot Number 2020110490;  SUT9790, Lot Number 2020112490;  SUT4020, Lot Number 2020122990;  SUT9790, Lot Number 2021012290;  SUT4020, Lot Number 2021022390;  SUT4020, Lot Number 2021041490;  SUT4020, Lot Number 2021060790;  SUT4020, Lot Number 2021070890;  SUT4020, Lot Number 2021092490;  SUT4020, Lot Number 2022011890;  SUT4020, Lot Number 2022041890;  SUT4020, Lot Number 2022062290;  SUT4020, Lot Number 2022091290;  SUT4020, Lot Number 2022121590;  SUT4020, Lot Number 2023070590;  UVT125, Lot Number 2019061990;  UVT125, Lot Number 2019080190;  UVT125, Lot Number 2023070690;  UVT125, Lot Number 2023083190;  MNS9580, Lot Number 2021120990;  MNS9580, Lot Number 2022062490;  MNS9580, Lot Number 2022091490;  MNS9580, Lot Number 2022111890;  MNS9580, Lot Number 2023012690;  MNS9580, Lot Number 2023022790;  MNS9580, Lot Number 2023042090;  MNS9580, Lot Number 2023071090;  MNS9580, Lot Number 2023081090;  MNS9580, Lot Number 2023102590;  MNS5460, Lot Number 2019112090;  MNS5460, Lot Number 2020032390;  MNS5460, Lot Number 2020070790;  UVT1080, Lot Number 2023061990;  UVT685, Lot Number 2019012180;  UVT685, Lot Number 2019042280;  UVT685, Lot Number 2019081980;  UVT685, Lot Number 2020011380;  UVT685, Lot Number 2021120680;  UVT685, Lot Number 2022071180;  MNS11020A, Lot Number 2020081090;  MNS11020A, Lot Number 2021100490. 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-2768-2024&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-2768-2024&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-2768-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2768-2024 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",
      "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-2768-2024&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-2768-2024&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-2768-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "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."
    }
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2768-2024",
            "Status": "recorded"
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        },
        {
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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        {
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        },
        {
          "@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": "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-08",
            "Status": "recorded"
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