{
  "@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-2194-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;",
  "description": "FDA recall Z-2194-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650; (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-2194-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2194-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2194-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;",
      "text": "The FDA logged enforcement record Z-2194-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a)\tVANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320;  b)\tCENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A;  c)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A;  d)\tTRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A;  e)\tCENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725;  f)\tINTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915;  g)\t20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B;  h)\tCVC BUNDLE KIT 20CM, Model Number ECVC2001;  i)\t16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A;  j)\tCVC BUNDLE KIT 16CM, Model Number ECVC2240A;  k)\tFIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320;  l)\t7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B;  m)\t16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555;  n)\t20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560;  o)\tFIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720;  p)\tCENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745;  q)\tCENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750;  r)\t7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770;  s)\tCVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895;  t)\tSHEATH INTRODUCER BUNDLE, Model Number ECVC2930;  u)\tDUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940;  v)\tTRIPLE LUMEN BUNDLE, Model Number ECVC2965;  w)\tTRIPLE LUMEN BUNDLE, Model Number ECVC3155;  x)\tCVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A;  y)\tCVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286;  z)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355;  aa)\tTRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395;  bb)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460;  cc)\t20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505;  dd)\t7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545;  ee)\tTRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A;  ff)\tCVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A;  gg)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785;  hh)\tMULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900;  ii)\tQUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135;  jj)\tAVA HIGH FLOW BUNDLE, Model Number ECVC4300;  kk)\t20CM 7F CVC INSERTION TRAY, Model Number ECVC4335;  ll)\tOLEAN GENERAL CVC BUNDLE, Model Number ECVC4615;  mm)\t3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A;  nn)\t3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A;  oo)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880;  pp)\tDUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985;  qq)\tQUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995;  rr)\t16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A;  ss)\tTRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015;  tt)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020;  uu)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A;  vv)\tVANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080;  ww)\t20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B;  xx)\tTRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200;  yy)\tTRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270;  zz)\tCVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310;  aaa)\tCVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315;  bbb)\tTRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B;  ccc)\tCVC ZONE DEFENSE BUNDLE, Model Number ECVC5385;  ddd)\tTRIPLE LUMEN BUNDLE, Model Number ECVC5475;  eee)\t7F, 16cm, 3L  MAX BARRIER CVC BUNDLE, Model Number ECVC5480;  fff)\tCVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A;  ggg)\tCNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A;  hhh)\tCVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A;  iii)\tCVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A;  jjj)\tCVC DOUBLE LUMEN 16CM, Model Number ECVC5585B;  kkk)\tCVC TRIPLE LUMEN 16CM, Model Number ECVC5590B;  lll)\tPI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650; — reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: All lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model number ECVC1320: UDI/DI (EA) 10653160335795, UDI/DI (CS) 00653160335798;  b) Model number ECVC1345A: UDI/DI (EA) 10653160334606, UDI/DI (CS) 00653160334609;  c) Model number ECVC1490A: UDI/DI (EA) 10653160359036, UDI/DI (CS) 00653160359039;  d) Model number ECVC1495A: UDI/DI (EA) 10653160358794, UDI/DI (CS) 00653160358797;  e) Model number ECVC1725: UDI/DI (EA) 10653160334507, UDI/DI (CS) 00653160334500;  f) Model number ECVC1915: UDI/DI (EA) 10653160334446, UDI/DI (CS) 00653160334449;  g) Model number ECVC1970B: UDI/DI (EA) 10653160357155, UDI/DI (CS) 00653160357158;  h) Model number ECVC2001: UDI/DI (EA) 10653160334415, UDI/DI (CS) 00653160334418;  i) Model number ECVC2205A: UDI/DI (EA) 10653160357148, UDI/DI (CS) 00653160357141;  j) Model number ECVC2240A: UDI/DI (EA) 10653160334361, UDI/DI (CS) 00653160334364;  k) Model number ECVC2320: UDI/DI (EA) 10653160332480, UDI/DI (CS) 00653160332483;  l) Model number ECVC2440B: UDI/DI (EA) 10653160358930, UDI/DI (CS) 00653160358933;  m) Model number ECVC2555: UDI/DI (EA) 10653160336570, UDI/DI (CS) 00653160336573;  n) Model number ECVC2560: UDI/DI (EA) 10653160334286, UDI/DI (CS) 00653160334289;  o) Model number ECVC2720: UDI/DI (EA) 10653160332657, UDI/DI (CS) 00653160332650;  p) Model number ECVC2745: UDI/DI (EA) 10653160334224, UDI/DI (CS) 00653160334227;  q) Model number ECVC2750: UDI/DI (EA) 10653160334217, UDI/DI (CS) 00653160334210;  r) Model number ECVC2770: UDI/DI (EA) 10653160332671, UDI/DI (CS) 00653160332674;  s) Model number ECVC2895: UDI/DI (EA) 10653160332725, UDI/DI (CS) 00653160332728;  t) Model number ECVC2930: UDI/DI (EA) 10653160335368, UDI/DI (CS) 00653160335361;  u) Model number ECVC2940: UDI/DI (EA) 10653160335351, UDI/DI (CS) 00653160335354;  v) Model number ECVC2965: UDI/DI (EA) 10653160338611, UDI/DI (CS) 00653160338614;  w) Model number ECVC3155: UDI/DI (EA) 10653160334132, UDI/DI (CS) 00653160334135;  x) Model number ECVC3285A: UDI/DI (EA) 10653160358572, UDI/DI (CS) 00653160358575;  y) Model number ECVC3286: UDI/DI (EA) 10653160358398, UDI/DI (CS) 00653160358391;  z) Model number ECVC3355: UDI/DI (EA) 10653160333982, UDI/DI (CS) 00653160333985;  aa) Model number ECVC3395: UDI/DI (EA) 10653160338635, UDI/DI (CS) 00653160338638;  bb) Model number ECVC3460: UDI/DI (EA) 10653160332794, UDI/DI (CS) 00653160332797;  cc) Model number ECVC3505: UDI/DI (EA) 10653160334767, UDI/DI (CS) 00653160334760;  dd) Model number ECVC3545: UDI/DI (EA) 10653160334774, UDI/DI (CS) 00653160334777;  ee) Model number ECVC3735A: UDI/DI (EA) 10653160334798, UDI/DI (CS) 00653160334791;  ff) Model number ECVC3755A: UDI/DI (EA) 10653160334804, UDI/DI (CS) 00653160334807;  gg) Model number ECVC3785: UDI/DI (EA) 10653160336006, UDI/DI (CS) 00653160336009;  hh) Model number ECVC3900: UDI/DI (EA) 10653160334828, UDI/DI (CS) 00653160334821;  ii) Model number ECVC4135: UDI/DI (EA) 10653160335900, UDI/DI (CS) 00653160335903;  jj) Model number ECVC4300: UDI/DI (EA) 10653160334873, UDI/DI (CS) 00653160334876;  kk) Model number ECVC4335: UDI/DI (EA) 10653160357285, UDI/DI (CS) 00653160357288;  ll) Model number ECVC4615: UDI/DI (EA) 10653160336075, UDI/DI (CS) 00653160336078;  mm) Model number ECVC4635A: UDI/DI (EA) 10653160352112, UDI/DI (CS) 00653160352115;  nn) Model number ECVC4640A: UDI/DI (EA) 10653160352105, UDI/DI (CS) 00653160352108;  oo) Model number ECVC4880: UDI/DI (EA) 10653160333111, UDI/DI (CS) 00653160333114;  pp) Model number ECVC4985: UDI/DI (EA) 10653160335269, UDI/DI (CS) 00653160335262;  qq) Model number ECVC4995: UDI/DI (EA) 10653160335283, UDI/DI (CS) 00653160335286;  rr) Model number ECVC5010A: UDI/DI (EA) 10653160335290, UDI/DI (CS) 00653160335293;  ss) Model number ECVC5015: UDI/DI (EA) 10653160338956, UDI/DI (CS) 00653160338959;  tt) Model number ECVC5020: UDI/DI (EA) 10653160334903, UDI/DI (CS) 00653160334906;  uu) Model number ECVC5020A: UDI/DI (EA) 10653160358251, UDI/DI (CS) 00653160358254;  vv) Model number ECVC5080: UDI/DI (EA) 10653160337690, UDI/DI (CS) 00653160337693;  ww) Model number ECVC5135B: UDI/DI (EA) 10653160353652, UDI/DI (CS) 00653160353655;  xx) Model number ECVC5200: UDI/DI (EA) 10653160336150, UDI/DI (CS) 00653160336153;  yy) Model number ECVC5270: UDI/DI (EA) 10653160336198, UDI/DI (CS) 00653160336191;  zz) Model number ECVC5310: UDI/DI (EA) 10653160336211, UDI/DI (CS) 00653160336214;  aaa) Model number ECVC5315: UDI/DI (EA) 10653160339465, UDI/DI (CS) 00653160339468;  bbb) Model number ECVC5355B: UDI/DI (EA) 10653160357742, UDI/DI (CS) 00653160357745;  ccc) Model number ECVC5385: UDI/DI (EA) 10653160336518, UDI/DI (CS) 00653160336511;  ddd) Model number ECVC5475: UDI/DI (EA) 10653160338116, UDI/DI (CS) 00653160338119;  eee) Model number ECVC5480: UDI/DI (EA) 10653160339458, UDI/DI (CS) 00653160339451;  fff) Model number ECVC5525A: UDI/DI (EA) 10653160338130, UDI/DI (CS) 00653160338133;  ggg) Model number ECVC5530A: UDI/DI (EA) 10653160345596, UDI/DI (CS) 00653160345599;  hhh) Model number ECVC5540A: UDI/DI (EA) 10653160335009, UDI/DI (CS) 00653160335002;  iii) Model number ECVC5560A: UDI/DI (EA) 10653160336501, UDI/DI (CS) 00653160336504;  jjj) Model number ECVC5585B: UDI/DI (EA) 10653160357711, UDI/DI (CS) 00653160357714;  kkk) Model number ECVC5590B: UDI/DI (EA) 10653160357728, UDI/DI (CS) 00653160357721;  lll) Model number ECVC5650: UDI/DI (EA) 10653160336457, UDI/DI (CS) 00653160336450;  mmm) Model number ECVC5655: UDI/DI (EA) 10653160337621, UDI/DI (CS) 00653160337624;  nnn) Model number ECVC5660: UDI/DI (EA) 10653160337638, UDI/DI (CS) 00653160337631;  ooo) Model number ECVC5665: UDI/DI (EA) 10653160341505, UDI/DI (CS) 00653160341508;  ppp) Model number ECVC5810: UDI/DI (EA) 10653160336419, UDI/DI (CS) 00653160336412;  qqq) Model number ECVC5815: UDI/DI (EA) 10653160336402, UDI/DI (CS) 00653160336405;  rrr) Model number ECVC5855B: UDI/DI (EA) 10653160355113, UDI/DI (CS) 00653160355116;  sss) Model number ECVC5870A: UDI/DI (EA) 10653160338383, UDI/DI (CS) 00653160338386;  ttt) Model number ECVC5985B: UDI/DI (EA) 10653160357797, UDI/DI (CS) 00653160357790;  uuu) Model number ECVC6015B: UDI/DI (EA) 10653160357704, UDI/DI (CS) 00653160357707;  vvv) Model number ECVC6070: UDI/DI (EA) 10653160335863, UDI/DI (CS) 00653160335866;  www) Model number ECVC6075: UDI/DI (EA) 10653160338437, UDI/DI (CS) 00653160338430;  xxx) Model number ECVC6120: UDI/DI (EA) 10653160336532, UDI/DI (CS) 00653160336535;  yyy) Model number ECVC6255: UDI/DI (EA) 10653160336525, UDI/DI (CS) 00653160336528;  zzz) Model number ECVC6260: UDI/DI (EA) 10653160336488, UDI/DI (CS) 00653160336481;  aaaa) Model number ECVC6265: UDI/DI (EA) 10653160342922, UDI/DI (CS) 00653160342925;  bbbb) Model number ECVC6340A: UDI/DI (EA) 10653160355038, UDI/DI (CS) 00653160355031;  cccc) Model number ECVC6355: UDI/DI (EA) 10653160336396, UDI/DI (CS) 00653160336399;  dddd) Model number ECVC6370: UDI/DI (EA) 10653160333425, UDI/DI (CS) 00653160333428;  eeee) Model number ECVC6490A: UDI/DI (EA) 10653160344360, UDI/DI (CS) 00653160344363;  ffff) Model number ECVC6505: UDI/DI (EA) 10653160336327, UDI/DI (CS) 00653160336320;  gggg) Model number ECVC6540: UDI/DI (EA) 10653160339397, UDI/DI (CS) 00653160339390;  hhhh) Model number ECVC6550: UDI/DI (EA) 10653160335276, UDI/DI (CS) 00653160335279;  iiii) Model number ECVC6555: UDI/DI (EA) 10653160336341, UDI/DI (CS) 00653160336344;  jjjj) Model number ECVC6585A: UDI/DI (EA) 10653160338826, UDI/DI (CS) 00653160338829;  kkkk) Model number ECVC6595: UDI/DI (EA) 10653160337485, UDI/DI (CS) 00653160337488;  llll) Model number ECVC6655A: UDI/DI (EA) 10653160339267, UDI/DI (CS) 00653160339260;  mmmm) Model number ECVC6680A: UDI/DI (EA) 10653160337164, UDI/DI (CS) 00653160337167;  nnnn) Model number ECVC6690: UDI/DI (EA) 10653160336600, UDI/DI (CS) 00653160336603;  oooo) Model number ECVC6765: UDI/DI (EA) 10653160336839, UDI/DI (CS) 00653160336832;  pppp) Model number ECVC6800: UDI/DI (EA) 10653160335092, UDI/DI (CS) 00653160335095;  qqqq) Model number ECVC6800A: UDI/DI (EA) 10653160355694, UDI/DI (CS) 00653160355697;  rrrr) Model number ECVC6815: UDI/DI (EA) 10653160335115, UDI/DI (CS) 00653160335118;  ssss) Model number ECVC6825A: UDI/DI (EA) 10653160336631, UDI/DI (CS) 00653160336634;  tttt) Model number ECVC6835: UDI/DI (EA) 10653160336778, UDI/DI (CS) 00653160336771;  uuuu) Model number ECVC6840: UDI/DI (EA) 10653160336761, UDI/DI (CS) 00653160336764;  vvvv) Model number ECVC6845: UDI/DI (EA) 10653160339366, UDI/DI (CS) 00653160339369;  wwww) Model number ECVC6850: UDI/DI (EA) 10653160338819, UDI/DI (CS) 00653160338812;  xxxx) Model number ECVC6915: UDI/DI (EA) 10653160336723, UDI/DI (CS) 00653160336726;  yyyy) Model number ECVC6920: UDI/DI (EA) 10653160336716, UDI/DI (CS) 00653160336719;  zzzz) Model number ECVC6970: UDI/DI (EA) 10653160336693, UDI/DI (CS) 00653160336696. 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-2194-2023&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-2194-2023&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-2194-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2194-2023 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-2194-2023&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-2194-2023&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-2194-2023/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-2194-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2194-2023",
            "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": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model number ECVC1320: UDI/DI (EA) 10653160335795, UDI/DI (CS) 00653160335798;  b) Model number ECVC1345A: UDI/DI (EA) 10653160334606, UDI/DI (CS) 00653160334609;  c) Model number ECVC1490A: UDI/DI (EA) 10653160359036, UDI/DI (CS) 00653160359039;  d) Model number ECVC1495A: UDI/DI (EA) 10653160358794, UDI/DI (CS) 00653160358797;  e) Model number ECVC1725: UDI/DI (EA) 10653160334507, UDI/DI (CS) 00653160334500;  f) Model number ECVC1915: UDI/DI (EA) 10653160334446, UDI/DI (CS) 00653160334449;  g) Model number ECVC1970B: UDI/DI (EA) 10653160357155, UDI/DI (CS) 00653160357158;  h) Model number ECVC2001: UDI/DI (EA) 10653160334415, UDI/DI (CS) 00653160334418;  i) Model number ECVC2205A: UDI/DI (EA) 10653160357148, UDI/DI (CS) 00653160357141;  j) Model number ECVC2240A: UDI/DI (EA) 10653160334361, UDI/DI (CS) 00653160334364;  k) Model number ECVC2320: UDI/DI (EA) 10653160332480, UDI/DI (CS) 00653160332483;  l) Model number ECVC2440B: UDI/DI (EA) 10653160358930, UDI/DI (CS) 00653160358933;  m) Model number ECVC2555: UDI/DI (EA) 10653160336570, UDI/DI (CS) 00653160336573;  n) Model number ECVC2560: UDI/DI (EA) 10653160334286, UDI/DI (CS) 00653160334289;  o) Model number ECVC2720: UDI/DI (EA) 10653160332657, UDI/DI (CS) 00653160332650;  p) Model number ECVC2745: UDI/DI (EA) 10653160334224, UDI/DI (CS) 00653160334227;  q) Model number ECVC2750: UDI/DI (EA) 10653160334217, UDI/DI (CS) 00653160334210;  r) Model number ECVC2770: UDI/DI (EA) 10653160332671, UDI/DI (CS) 00653160332674;  s) Model number ECVC2895: UDI/DI (EA) 10653160332725, UDI/DI (CS) 00653160332728;  t) Model number ECVC2930: UDI/DI (EA) 10653160335368, UDI/DI (CS) 00653160335361;  u) Model number ECVC2940: UDI/DI (EA) 10653160335351, UDI/DI (CS) 00653160335354;  v) Model number ECVC2965: UDI/DI (EA) 10653160338611, UDI/DI (CS) 00653160338614;  w) Model number ECVC3155: UDI/DI (EA) 10653160334132, UDI/DI (CS) 00653160334135;  x) Model number ECVC3285A: UDI/DI (EA) 10653160358572, UDI/DI (CS) 00653160358575;  y) Model number ECVC3286: UDI/DI (EA) 10653160358398, UDI/DI (CS) 00653160358391;  z) Model number ECVC3355: UDI/DI (EA) 10653160333982, UDI/DI (CS) 00653160333985;  aa) Model number ECVC3395: UDI/DI (EA) 10653160338635, UDI/DI (CS) 00653160338638;  bb) Model number ECVC3460: UDI/DI (EA) 10653160332794, UDI/DI (CS) 00653160332797;  cc) Model number ECVC3505: UDI/DI (EA) 10653160334767, UDI/DI (CS) 00653160334760;  dd) Model number ECVC3545: UDI/DI (EA) 10653160334774, UDI/DI (CS) 00653160334777;  ee) Model number ECVC3735A: UDI/DI (EA) 10653160334798, UDI/DI (CS) 00653160334791;  ff) Model number ECVC3755A: UDI/DI (EA) 10653160334804, UDI/DI (CS) 00653160334807;  gg) Model number ECVC3785: UDI/DI (EA) 10653160336006, UDI/DI (CS) 00653160336009;  hh) Model number ECVC3900: UDI/DI (EA) 10653160334828, UDI/DI (CS) 00653160334821;  ii) Model number ECVC4135: UDI/DI (EA) 10653160335900, UDI/DI (CS) 00653160335903;  jj) Model number ECVC4300: UDI/DI (EA) 10653160334873, UDI/DI (CS) 00653160334876;  kk) Model number ECVC4335: UDI/DI (EA) 10653160357285, UDI/DI (CS) 00653160357288;  ll) Model number ECVC4615: UDI/DI (EA) 10653160336075, UDI/DI (CS) 00653160336078;  mm) Model number ECVC4635A: UDI/DI (EA) 10653160352112, UDI/DI (CS) 00653160352115;  nn) Model number ECVC4640A: UDI/DI (EA) 10653160352105, UDI/DI (CS) 00653160352108;  oo) Model number ECVC4880: UDI/DI (EA) 10653160333111, UDI/DI (CS) 00653160333114;  pp) Model number ECVC4985: UDI/DI (EA) 10653160335269, UDI/DI (CS) 00653160335262;  qq) Model number ECVC4995: UDI/DI (EA) 10653160335283, UDI/DI (CS) 00653160335286;  rr) Model number ECVC5010A: UDI/DI (EA) 10653160335290, UDI/DI (CS) 00653160335293;  ss) Model number ECVC5015: UDI/DI (EA) 10653160338956, UDI/DI (CS) 00653160338959;  tt) Model number ECVC5020: UDI/DI (EA) 10653160334903, UDI/DI (CS) 00653160334906;  uu) Model number ECVC5020A: UDI/DI (EA) 10653160358251, UDI/DI (CS) 00653160358254;  vv) Model number ECVC5080: UDI/DI (EA) 10653160337690, UDI/DI (CS) 00653160337693;  ww) Model number ECVC5135B: UDI/DI (EA) 10653160353652, UDI/DI (CS) 00653160353655;  xx) Model number ECVC5200: UDI/DI (EA) 10653160336150, UDI/DI (CS) 00653160336153;  yy) Model number ECVC5270: UDI/DI (EA) 10653160336198, UDI/DI (CS) 00653160336191;  zz) Model number ECVC5310: UDI/DI (EA) 10653160336211, UDI/DI (CS) 00653160336214;  aaa) Model number ECVC5315: UDI/DI (EA) 10653160339465, UDI/DI (CS) 00653160339468;  bbb) Model number ECVC5355B: UDI/DI (EA) 10653160357742, UDI/DI (CS) 00653160357745;  ccc) Model number ECVC5385: UDI/DI (EA) 10653160336518, UDI/DI (CS) 00653160336511;  ddd) Model number ECVC5475: UDI/DI (EA) 10653160338116, UDI/DI (CS) 00653160338119;  eee) Model number ECVC5480: UDI/DI (EA) 10653160339458, UDI/DI (CS) 00653160339451;  fff) Model number ECVC5525A: UDI/DI (EA) 10653160338130, UDI/DI (CS) 00653160338133;  ggg) Model number ECVC5530A: UDI/DI (EA) 10653160345596, UDI/DI (CS) 00653160345599;  hhh) Model number ECVC5540A: UDI/DI (EA) 10653160335009, UDI/DI (CS) 00653160335002;  iii) Model number ECVC5560A: UDI/DI (EA) 10653160336501, UDI/DI (CS) 00653160336504;  jjj) Model number ECVC5585B: UDI/DI (EA) 10653160357711, UDI/DI (CS) 00653160357714;  kkk) Model number ECVC5590B: UDI/DI (EA) 10653160357728, UDI/DI (CS) 00653160357721;  lll) Model number ECVC5650: UDI/DI (EA) 10653160336457, UDI/DI (CS) 00653160336450;  mmm) Model number ECVC5655: UDI/DI (EA) 10653160337621, UDI/DI (CS) 00653160337624;  nnn) Model number ECVC5660: UDI/DI (EA) 10653160337638, UDI/DI (CS) 00653160337631;  ooo) Model number ECVC5665: UDI/DI (EA) 10653160341505, UDI/DI (CS) 00653160341508;  ppp) Model number ECVC5810: UDI/DI (EA) 10653160336419, UDI/DI (CS) 00653160336412;  qqq) Model number ECVC5815: UDI/DI (EA) 10653160336402, UDI/DI (CS) 00653160336405;  rrr) Model number ECVC5855B: UDI/DI (EA) 10653160355113, UDI/DI (CS) 00653160355116;  sss) Model number ECVC5870A: UDI/DI (EA) 10653160338383, UDI/DI (CS) 00653160338386;  ttt) Model number ECVC5985B: UDI/DI (EA) 10653160357797, UDI/DI (CS) 00653160357790;  uuu) Model number ECVC6015B: UDI/DI (EA) 10653160357704, UDI/DI (CS) 00653160357707;  vvv) Model number ECVC6070: UDI/DI (EA) 10653160335863, UDI/DI (CS) 00653160335866;  www) Model number ECVC6075: UDI/DI (EA) 10653160338437, UDI/DI (CS) 00653160338430;  xxx) Model number ECVC6120: UDI/DI (EA) 10653160336532, UDI/DI (CS) 00653160336535;  yyy) Model number ECVC6255: UDI/DI (EA) 10653160336525, UDI/DI (CS) 00653160336528;  zzz) Model number ECVC6260: UDI/DI (EA) 10653160336488, UDI/DI (CS) 00653160336481;  aaaa) Model number ECVC6265: UDI/DI (EA) 10653160342922, UDI/DI (CS) 00653160342925;  bbbb) Model number ECVC6340A: UDI/DI (EA) 10653160355038, UDI/DI (CS) 00653160355031;  cccc) Model number ECVC6355: UDI/DI (EA) 10653160336396, UDI/DI (CS) 00653160336399;  dddd) Model number ECVC6370: UDI/DI (EA) 10653160333425, UDI/DI (CS) 00653160333428;  eeee) Model number ECVC6490A: UDI/DI (EA) 10653160344360, UDI/DI (CS) 00653160344363;  ffff) Model number ECVC6505: UDI/DI (EA) 10653160336327, UDI/DI (CS) 00653160336320;  gggg) Model number ECVC6540: UDI/DI (EA) 10653160339397, UDI/DI (CS) 00653160339390;  hhhh) Model number ECVC6550: UDI/DI (EA) 10653160335276, UDI/DI (CS) 00653160335279;  iiii) Model number ECVC6555: UDI/DI (EA) 10653160336341, UDI/DI (CS) 00653160336344;  jjjj) Model number ECVC6585A: UDI/DI (EA) 10653160338826, UDI/DI (CS) 00653160338829;  kkkk) Model number ECVC6595: UDI/DI (EA) 10653160337485, UDI/DI (CS) 00653160337488;  llll) Model number ECVC6655A: UDI/DI (EA) 10653160339267, UDI/DI (CS) 00653160339260;  mmmm) Model number ECVC6680A: UDI/DI (EA) 10653160337164, UDI/DI (CS) 00653160337167;  nnnn) Model number ECVC6690: UDI/DI (EA) 10653160336600, UDI/DI (CS) 00653160336603;  oooo) Model number ECVC6765: UDI/DI (EA) 10653160336839, UDI/DI (CS) 00653160336832;  pppp) Model number ECVC6800: UDI/DI (EA) 10653160335092, UDI/DI (CS) 00653160335095;  qqqq) Model number ECVC6800A: UDI/DI (EA) 10653160355694, UDI/DI (CS) 00653160355697;  rrrr) Model number ECVC6815: UDI/DI (EA) 10653160335115, UDI/DI (CS) 00653160335118;  ssss) Model number ECVC6825A: UDI/DI (EA) 10653160336631, UDI/DI (CS) 00653160336634;  tttt) Model number ECVC6835: UDI/DI (EA) 10653160336778, UDI/DI (CS) 00653160336771;  uuuu) Model number ECVC6840: UDI/DI (EA) 10653160336761, UDI/DI (CS) 00653160336764;  vvvv) Model number ECVC6845: UDI/DI (EA) 10653160339366, UDI/DI (CS) 00653160339369;  wwww) Model number ECVC6850: UDI/DI (EA) 10653160338819, UDI/DI (CS) 00653160338812;  xxxx) Model number ECVC6915: UDI/DI (EA) 10653160336723, UDI/DI (CS) 00653160336726;  yyyy) Model number ECVC6920: UDI/DI (EA) 10653160336716, UDI/DI (CS) 00653160336719;  zzzz) Model number ECVC6970: UDI/DI (EA) 10653160336693, UDI/DI (CS) 00653160336696",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}