{
  "@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-2179-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI",
  "description": "FDA recall Z-2179-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI (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-2179-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2179-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2179-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI",
      "text": "The FDA logged enforcement record Z-2179-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:   a)\tNO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115;  b)\tMAJOR VASCULAR, Model Number CDS980752I;  c)\tPICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F;  d)\tPICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F;  e)\tCHP TRANSPLANT CDS, Model Number CDS983082J;  f)\tCLOSURE CDS, Model Number CDS983704I;  g)\tMIDLINE INSERTION TRAY, Model Number CVI4340;  h)\tPORT INSERTION PACK, Model Number CVI4765;  i)\tMAX BARRIER KIT, Model Number DYND2673B;  j)\tPOWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C;  k)\tDEPIPPO PACK, Model Number DYNDA2011B;  l)\tVEIN PROCEDURE KIT, Model Number DYNDA2076;  m)\tSCLEROTHERAPY KIT, Model Number DYNDA2148A;  n)\tIR SONO PACK, Model Number DYNDA2365B;  o)\tULTRASOUND BASIC KIT, Model Number DYNDC2099;  p)\tPIV WITH ULTRASOUND KIT, Model Number DYNDC2399A;  q)\tPARA THORACENTESIS TRAY, Model Number DYNDH1165A;  r)\tULTRASOUND TRAY, Model Number DYNDH1204;  s)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1292;  t)\tULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319;  u)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470B;  v)\tPARA/THORACENTESIS TRAY, Model Number DYNDH1470C;  w)\tUS GUIDED LOC KIT, Model Number DYNDH1492;  x)\tAMINO KIT, Model Number DYNDH1649;  y)\tBREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A;  z)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B;  aa)\tULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A;  bb)\tCVL PACK, Model Number DYNJ00281N;  cc)\tFEM POP PACK, Model Number DYNJ01964M;  dd)\tMAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D;  ee)\tVEIN PACK, Model Number DYNJ0309084D;  ff)\tDR. BAHDOUCH PACK, Model Number DYNJ0351069;  gg)\tANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q;  hh)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y;  ii)\tJUDKINS PACK-LF, Model Number DYNJ0530948AR;  jj)\tJUDKINS PACK-LF, Model Number DYNJ0586030P;  kk)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q;  ll)\tMINI PACK-LF, Model Number DYNJ0604540P;  mm)\tMINI PACK-LF, Model Number DYNJ0604540Q;  nn)\tBIOPSY PACK-LF, Model Number DYNJ0747885F;  oo)\tPERC PACK-LF, Model Number DYNJ0774759O;  pp)\tPERC PACK-LF, Model Number DYNJ0774759P;  qq)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821N;  rr)\tRR-SPECIAL PROCEDURE  PACK-LF, Model Number DYNJ0785821O;  ss)\tCLOSURE PACK-LF, Model Number DYNJ0807503M;  tt)\tLINE PLACEMENT PACK-LF, Model Number DYNJ0931376F;  uu)\tDENTAL PACK-LF, Model Number DYNJ0952428;  vv)\tVENOUS ACCESS TRAY, Model Number DYNJ20094K;  ww)\tDEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ32397B;  yy)\tLARGE PROCEDURE PACK, Model Number DYNJ35524D;  zz)\tRAD CVC TRAY, Model Number DYNJ35574A;  aaa)\tWILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J;  bbb)\tWILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G;  ccc)\tSTERILE PICC TRAY-LF, Model Number DYNJ36814B;  ddd)\tPARA/THORA PACK, Model Number DYNJ37280C;  eee)\tBASIC PACK, Model Number DYNJ37460A;  fff)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F;  ggg)\tMINOR PROCEDURE PACK, Model Number DYNJ38563O;  hhh)\tVEIN PACK, Model Number DYNJ38682C;  iii)\tADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B;  jjj)\tPICC LINE INSERTION, Model Number DYNJ39885A;  kkk)\tPEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A;  lll)\tHL VEIN STRIPPING PACK, Model Number DYNJ40374A;  mmm)\tGENERAL USE PACK, Model Number DYNJ41137B;  nnn)\tPICC LINE INSERTION WRO-LF, Model Number DYNJ41873B;  ooo)\tCV ACCESS PACK WRO-LF, Model Number DYNJ41875B;  ppp)\tRADIOLOGY PACK, Model Number DYNJ42172A;  qqq)\tBASIC PACK, Model Number DYNJ42691;  rrr)\tDRAINAGE TRAY, Model Number DYNJ42913;  sss)\tDRAINAGE TRAY, Model Number DYNJ42913A;  ttt)\tIR MINI KIT, Model Number DYNJ44519F;  uuu)\tIR PERIPHERAL PACK, Model Number DYNJ45033A;  vvv)\tEVLT CORE PACK, Model Number DYNJ45294;  www)\tEVLT PACK, Model Number DYNJ45997C;  xxx)\tPHLEBECTOMY PACK, Model Number DYNJ47502B;  yyy)\tLINE KIT, Model Number DYNJ47987B;  zzz)\tVEI — 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 ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339;  b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541;  c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216;  d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209;  e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515;  f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559;  g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476;  h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184;  i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359;  j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177;  k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027;  l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506;  m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037;  n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449;  o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675;  p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934;  q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509;  r) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836;  s) Model Number DYNDH1292, UDI/DI (EA) 10889942742233, UDI/DI (CS) 40889942742234;  t) Model Number DYNDH1319, UDI/DI (EA) 10889942795475, UDI/DI (CS) 40889942795476;  u) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 40193489111249;  v) Model Number DYNDH1470C, UDI/DI (EA) 10195327297718, UDI/DI (CS) 40195327297719;  w) Model Number DYNDH1492, UDI/DI (EA) 10193489434460, UDI/DI (CS) 40193489434461;  x) Model Number DYNDH1649, UDI/DI (EA) 10193489944365, UDI/DI (CS) 40193489944366;  y) Model Number DYNDL1596A, UDI/DI (EA) 10884389926505, UDI/DI (CS) 40884389926506;  z) Model Number DYNDV2038B, UDI/DI (EA) 10193489919837, UDI/DI (CS) 40193489919838;  aa) Model Number DYNDV2385A, UDI/DI (EA) 10195327298760, UDI/DI (CS) 40195327298761;  bb) Model Number DYNJ00281N, UDI/DI (EA) 10193489449808, UDI/DI (CS) 40193489449809;  cc) Model Number DYNJ01964M, UDI/DI (EA) 10193489648034, UDI/DI (CS) 40193489648035;  dd) Model Number DYNJ0248546D, UDI/DI (EA) 10195327069285, UDI/DI (CS) 40195327069286;  ee) Model Number DYNJ0309084D, UDI/DI (EA) 10889942885268, UDI/DI (CS) 40889942885269;  ff) Model Number DYNJ0351069, UDI/DI (EA) 10889942059058, UDI/DI (CS) 40889942059059;  gg) Model Number DYNJ0370436Q, UDI/DI (EA) 10888277779280, UDI/DI (CS) 40888277779281;  hh) Model Number DYNJ0416535Y, UDI/DI (EA) 10193489994056, UDI/DI (CS) 40193489994057;  ii) Model Number DYNJ0530948AR, UDI/DI (EA) 10195327141882, UDI/DI (CS) 40195327141883;  jj) Model Number DYNJ0586030P, UDI/DI (EA) 10889942947140, UDI/DI (CS) 40889942947141;  kk) Model Number DYNJ0604508Q, UDI/DI (EA) 10193489560190, UDI/DI (CS) 40193489560191;  ll) Model Number DYNJ0604540P, UDI/DI (EA) 10193489560206, UDI/DI (CS) 40193489560207;  mm) Model Number DYNJ0604540Q, UDI/DI (EA) 10193489839685, UDI/DI (CS) 40193489839686;  nn) Model Number DYNJ0747885F, UDI/DI (EA) 10193489542318, UDI/DI (CS) 40193489542319;  oo) Model Number DYNJ0774759O, UDI/DI (EA) 10195327091859, UDI/DI (CS) 40195327091850;  pp) Model Number DYNJ0774759P, UDI/DI (EA) 10195327246136, UDI/DI (CS) 40195327246137;  qq) Model Number DYNJ0785821N, UDI/DI (EA) 10193489915792, UDI/DI (CS) 40193489915793;  rr) Model Number DYNJ0785821O, UDI/DI (EA) 10195327263737, UDI/DI (CS) 40195327263738;  ss) Model Number DYNJ0807503M, UDI/DI (EA) 10889942091737, UDI/DI (CS) 40889942091738;  tt) Model Number DYNJ0931376F, UDI/DI (EA) 10193489271508, UDI/DI (CS) 40193489271509;  uu) Model Number DYNJ0952428, UDI/DI (EA) 10889942101610, UDI/DI (CS) 40889942101611;  vv) Model Number DYNJ20094K, UDI/DI (EA) 10193489213256, UDI/DI (CS) 40193489213257;  ww) Model Number DYNJ31934D, UDI/DI (EA) 10195327071509, UDI/DI (CS) 40195327071500;  xx) Model Number DYNJ32397B, UDI/DI (EA) 10884389916650, UDI/DI (CS) 40884389916651;  yy) Model Number DYNJ35524D, UDI/DI (EA) 10193489766103, UDI/DI (CS) 40193489766104;  zz) Model Number DYNJ35574A, UDI/DI (EA) 10884389538067, UDI/DI (CS) 40884389538068;  aaa) Model Number DYNJ35988J, UDI/DI (EA) 10195327024666, UDI/DI (CS) 40195327024667;  bbb) Model Number DYNJ35989G, UDI/DI (EA) 10195327024673, UDI/DI (CS) 40195327024674;  ccc) Model Number DYNJ36814B, UDI/DI (EA) 10195327075576, UDI/DI (CS) 40195327075577;  ddd) Model Number DYNJ37280C, UDI/DI (EA) 10889942431656, UDI/DI (CS) 40889942431657;  eee) Model Number DYNJ37460A, UDI/DI (EA) 10888277560437, UDI/DI (CS) 40888277560438;  fff) Model Number DYNJ38326F, UDI/DI (EA) 10193489236675, UDI/DI (CS) 40193489236676;  ggg) Model Number DYNJ38563O, UDI/DI (EA) 10193489251746, UDI/DI (CS) 40193489251747;  hhh) Model Number DYNJ38682C, UDI/DI (EA) 10889942897193, UDI/DI (CS) 40889942897194;  iii) Model Number DYNJ38714B, UDI/DI (EA) 10889942601936, UDI/DI (CS) 40889942601937;  jjj) Model Number DYNJ39885A, UDI/DI (EA) 10889942539932, UDI/DI (CS) 40889942539933;  kkk) Model Number DYNJ40306A, UDI/DI (EA) 10889942601929, UDI/DI (CS) 40889942601920;  lll) Model Number DYNJ40374A, UDI/DI (EA) 10888277557949, UDI/DI (CS) 40888277557940;  mmm) Model Number DYNJ41137B, UDI/DI (EA) 10889942260874, UDI/DI (CS) 40889942260875;  nnn) Model Number DYNJ41873B, UDI/DI (EA) 10193489563061, UDI/DI (CS) 40193489563062;  ooo) Model Number DYNJ41875B, UDI/DI (EA) 10193489563078, UDI/DI (CS) 40193489563079;  ppp) Model Number DYNJ42172A, UDI/DI (EA) 10193489502718, UDI/DI (CS) 40193489502719;  qqq) Model Number DYNJ42691, UDI/DI (EA) 10888277003507, UDI/DI (CS) 40888277003508;  rrr) Model Number DYNJ42913, UDI/DI (EA) 10888277013209, UDI/DI (CS) 40888277013200;  sss) Model Number DYNJ42913A, UDI/DI (EA) 10195327080600, UDI/DI (CS) 40195327080601;  ttt) Model Number DYNJ44519F, UDI/DI (EA) 10193489467475, UDI/DI (CS) 40193489467476;  uuu) Model Number DYNJ45033A, UDI/DI (EA) 10193489475807, UDI/DI (CS) 40193489475808;  vvv) Model Number DYNJ45294, UDI/DI (EA) 10888277098978, UDI/DI (CS) 40888277098979;  www) Model Number DYNJ45997C, UDI/DI (EA) 10889942684366, UDI/DI (CS) 40889942684367;  xxx) Model Number DYNJ47502B, UDI/DI (EA) 10193489649222, UDI/DI (CS) 40193489649223;  yyy) Model Number DYNJ47987B, UDI/DI (EA) 10193489867374, UDI/DI (CS) 40193489867375;  zzz) Model Number DYNJ48454, UDI/DI (EA) 10888277595286, UDI/DI (CS) 40888277595287;  aaaa) Model Number DYNJ48456B, UDI/DI (EA) 10889942733170, UDI/DI (CS) 40889942733171;  bbbb) Model Number DYNJ49177F, UDI/DI (EA) 10888277774346, UDI/DI (CS) 40888277774347;  cccc) Model Number DYNJ49737C, UDI/DI (EA) 10195327235888, UDI/DI (CS) 40195327235889;  dddd) Model Number DYNJ51248B, UDI/DI (EA) 10889942873401, UDI/DI (CS) 40889942873402;  eeee) Model Number DYNJ51340D, UDI/DI (EA) 10193489569810, UDI/DI (CS) 40193489569811;  ffff) Model Number DYNJ51638C, UDI/DI (EA) 10195327039561, UDI/DI (CS) 40195327039562;  gggg) Model Number DYNJ51705B, UDI/DI (EA) 10193489877175, UDI/DI (CS) 40193489877176;  hhhh) Model Number DYNJ52122B, UDI/DI (EA) 10193489935301, UDI/DI (CS) 40193489935302;  iiii) Model Number DYNJ52122C, UDI/DI (EA) 10195327260088, UDI/DI (CS) 40195327260089;  jjjj) Model Number DYNJ52171, UDI/DI (EA) 10889942243471, UDI/DI (CS) 40889942243472;  kkkk) Model Number DYNJ53122B, UDI/DI (EA) 10193489321227, UDI/DI (CS) 40193489321228;  llll) Model Number DYNJ53135C, UDI/DI (EA) 10193489468434, UDI/DI (CS) 40193489468435;  mmmm) Model Number DYNJ53319C, UDI/DI (EA) 10193489634495, UDI/DI (CS) 40193489634496;  nnnn) Model Number DYNJ53435C, UDI/DI (EA) 10193489200867, UDI/DI (CS) 40193489200868;  oooo) Model Number DYNJ53482A, UDI/DI (EA) 10889942917310, UDI/DI (CS) 40889942917311;  pppp) Model Number DYNJ53658A, UDI/DI (EA) 10889942684403, UDI/DI (CS) 40889942684404;  qqqq) Model Number DYNJ54131, UDI/DI (EA) 10889942466801, UDI/DI (CS) 40889942466802;  rrrr) Model Number DYNJ54265, UDI/DI (EA) 10889942474004, UDI/DI (CS) 40889942474005;  ssss) Model Number DYNJ54437C, UDI/DI (EA) 10193489243970, UDI/DI (CS) 40193489243971;  tttt) Model Number DYNJ54569A, UDI/DI (EA) 10193489742954, UDI/DI (CS) 40193489742955;  uuuu) Model Number DYNJ54894A, UDI/DI (EA) 10193489213553, UDI/DI (CS) 40193489213554;  vvvv) Model Number DYNJ55063A, UDI/DI (EA) 10193489680546, UDI/DI (CS) 40193489680547;  wwww) Model Number DYNJ55456, UDI/DI (EA) 10889942548446, UDI/DI (CS) 40889942548447;  xxxx) Model Number DYNJ55457, UDI/DI (EA) 10889942548460, UDI/DI (CS) 40889942548461;  yyyy) Model Number DYNJ55458, UDI/DI (EA) 10889942548453, UDI/DI (CS) 40889942548454;  zzzz) Model Number DYNJ55723A, UDI/DI (EA) 10889942865536, UDI/DI (CS) 40889942865537. 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-2179-2023&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-2179-2023&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-2179-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2179-2023 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-2179-2023&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-2179-2023&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-2179-2023/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."
    }
  ],
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      "name": "FDA recall details — Z-2179-2023",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2179-2023",
            "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"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
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            "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"
          }
        }
      ]
    }
  ]
}