{
  "@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-2167-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL BUNDLE NO CATHETER, Model Number ART995;  b)\tART LINE KIT NO CATH, Model Number ARTNC145;  c)\tCENTRAL LINE TRAY, Model Number CVI4705;  d)\tCENTRAL LINE INSERTION PACK, Model Number CVI4805;  e)\tED CENTRAL LINE KIT, Model Number CVI4865;  f)\tNO CATH MIDLINE INSERTION KIT, Model Number CVI4950A;  g)\tCENTRAL LINE PROCEDURE KIT, Model Number DT22260;  h)\tADULT EPIV INSERTION TRAY, Model Number DYNDA2482;  i)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669;  j)\tI.R. PICC PACK, Model Number DYNDA2759;  k)\tIR SONO PACK, Model Number DYNDA3010;  l)\tNEONATAL PICC LINE TRAY, Model Number DYNDC2120B;  m)\tPICC SUPPLEMENTAL KIT, Model Number DYNDC2373A;  n)\tCENTRAL LINE KIT, Model Number DYNDC2582A;  o)\tCENTRAL LINE KIT UTMB, Model Number DYNDC3061;  p)\tFNA TRAY, Model Number DYNDH1123B;  q)\tCVL PACK, Model Number DYNJ00281O;  r)\tCENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O;  s)\tCENTRAL LINE PACK-LF, Model Number DYNJ0220136Q;  t)\tPICC LINE PACK-LF, Model Number DYNJ0235859I;  u)\tPICC LINE PACK-LF, Model Number DYNJ0235859J;  v)\tPICC LINE PACK-LF, Model Number DYNJ0235859K;  w)\tPICC LINE PACK, Model Number DYNJ04592K;  x)\tPICC LINE PACK-LF, Model Number DYNJ0678523N;  y)\tPICC LINE PACK-LF, Model Number DYNJ0855123N;  z)\tPICC INSERTION PACK-LF, Model Number DYNJ0880659F;  aa)\tPICC PACK-LF, Model Number DYNJ0940720D;  bb)\tVENOUS ACCESS PACK-LF, Model Number DYNJ09895R;  cc)\tPICC PACK-LF, Model Number DYNJ17086A;  dd)\tVENOUS ACCESS TRAY, Model Number DYNJ20094L;  ee)\tPICC LINE PACK-LF, Model Number DYNJ21575I;  ff)\tCENTRAL LINE PACK, Model Number DYNJ30087C;  gg)\tPICC LINE PACK, Model Number DYNJ30233C;  hh)\tPICC PACK, Model Number DYNJ30566B;  ii)\tCENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G;  jj)\tPICC TRAY, Model Number DYNJ33005F;  kk)\tPICC TRAY, Model Number DYNJ33005G;  ll)\tPICC LINE INSERTION TRAY, Model Number DYNJ34241;  mm)\tPICC PACK-LF, Model Number DYNJ35000I;  nn)\tPORT PACK, Model Number DYNJ35163C;  oo)\tPICC TRAY-LF, Model Number DYNJ35272;  pp)\tPICC LINE INSERTION PACK, Model Number DYNJ38868K;  qq)\tPICC LINE INSERTION PACK, Model Number DYNJ38868L;  rr)\tPICC ACCESSORY TRAY, Model Number DYNJ39039M;  ss)\tCVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B;  tt)\tPICC INSERTION PACK MH-LF, Model Number DYNJ40206B;  uu)\tACCESS PICC PACK, Model Number DYNJ40682B;  vv)\tPHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C;  ww)\tMV-IR-PICC PACK-LF, Model Number DYNJ41554C;  xx)\tPICC TRAY, Model Number DYNJ41648;  yy)\tCENTRAL LINE TRAY, Model Number DYNJ42902C;  zz)\tCENTRAL LINE TRAY, Model Number DYNJ42902D;  aaa)\tVENOUS PACK, Model Number DYNJ43168;  bbb)\tVENOUS PACK, Model Number DYNJ43168A;  ccc)\tVENOUS PACK, Model Number DYNJ43168B;  ddd)\tIR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G;  eee)\tWEST VALLEY PICC LINE PACK, Model Number DYNJ43975A;  fff)\tVENOUS LIGATION PACK, Model Number DYNJ43981G;  ggg)\tVEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C;  hhh)\tVENOUS ABLATION, Model Number DYNJ44904C;  iii)\tPICC LINE PACK, Model Number DYNJ47037C;  jjj)\tPICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B;  kkk)\tCENTRAL LINE PACK, Model Number DYNJ48096B;  lll)\tPICC PACK-LF, Model Number DYNJ48120B;  mmm)\tAV FISTULA PACK-LF, Model Number DYNJ48428C;  nnn)\tVIEN CLOSURE, Model Number DYNJ49180A;  ooo)\tARTERIAL LINE PACK, Model Number DYNJ49235D;  ppp)\tPICC PACK, Model Number DYNJ52255;  qqq)\tPICC LINE TRAY, Model Number DYNJ52688B;  rrr)\tPICC LINE TRAY, Model Number DYNJ52688C;  sss)\tCENTRAL LINE INSERTION KIT, Model Number DYNJ52894A;  ttt)\tARTERIOGRAM PACK, Model Number DYNJ53095A;  uuu)\tENDOVENOUS ABLATION PACK, Model Number DYNJ53435D;  vvv)\tMID HUDSON PICC LINE PACK, Model Number DYNJ53618A;  www)\tMSB BEDSIDE TRAY, Model Number DYNJ54670;  xxx)\tLEE VEIN PACK, Model Number DYNJ54906C;  yyy)\tARTERIOGRAM PACK, Model Number DYNJ55169G;  zzz)\tPICC LINE PACK, Model Number DYNJ55170B;  aaaa)\tPICC LINE PACK, M",
  "description": "FDA recall Z-2167-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL BUNDLE NO CATHETER, Model Number ART995;  b)\tART LINE KIT NO CATH, Model Number ARTNC145;  c)\tCENTRAL LINE TRAY, Model Number CVI4705;  d)\tCENTRAL LINE INSERTION PACK, Model Number CVI4805;  e)\tED CENTRAL LINE KIT, Model Number CVI4865;  f)\tNO CATH MIDLINE INSERTION KIT, Model Number CVI4950A;  g)\tCENTRAL LINE PROCEDURE KIT, Model Number DT22260;  h)\tADULT EPIV INSERTION TRAY, Model Number DYNDA2482;  i)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669;  j)\tI.R. PICC PACK, Model Number DYNDA2759;  k)\tIR SONO PACK, Model Number DYNDA3010;  l)\tNEONATAL PICC LINE TRAY, Model Number DYNDC2120B;  m)\tPICC SUPPLEMENTAL KIT, Model Number DYNDC2373A;  n)\tCENTRAL LINE KIT, Model Number DYNDC2582A;  o)\tCENTRAL LINE KIT UTMB, Model Number DYNDC3061;  p)\tFNA TRAY, Model Number DYNDH1123B;  q)\tCVL PACK, Model Number DYNJ00281O;  r)\tCENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O;  s)\tCENTRAL LINE PACK-LF, Model Number DYNJ0220136Q;  t)\tPICC LINE PACK-LF, Model Number DYNJ0235859I;  u)\tPICC LINE PACK-LF, Model Number DYNJ0235859J;  v)\tPICC LINE PACK-LF, Model Number DYNJ0235859K;  w)\tPICC LINE PACK, Model Number DYNJ04592K;  x)\tPICC LINE PACK-LF, Model Number DYNJ0678523N;  y)\tPICC LINE PACK-LF, Model Number DYNJ0855123N;  z)\tPICC INSERTION PACK-LF, Model Number DYNJ0880659F;  aa)\tPICC PACK-LF, Model Number DYNJ0940720D;  bb)\tVENOUS ACCESS PACK-LF, Model Number DYNJ09895R;  cc)\tPICC PACK-LF, Model Number DYNJ17086A;  dd)\tVENOUS ACCESS TRAY, Model Number DYNJ20094L;  ee)\tPICC LINE PACK-LF, Model Number DYNJ21575I;  ff)\tCENTRAL LINE PACK, Model Number DYNJ30087C;  gg)\tPICC LINE PACK, Model Number DYNJ30233C;  hh)\tPICC PACK, Model Number DYNJ30566B;  ii)\tCENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G;  jj)\tPICC TRAY, Model Number DYNJ33005F;  kk)\tPICC TRAY, Model Number DYNJ33005G;  ll)\tPICC LINE INSERTION TRAY, Model Number DYNJ34241;  mm)\tPICC PACK-LF, Model Number DYNJ35000I;  nn)\tPORT PACK, Model Number DYNJ35163C;  oo)\tPICC TRAY-LF, Model Number DYNJ35272;  pp)\tPICC LINE INSERTION PACK, Model Number DYNJ38868K;  qq)\tPICC LINE INSERTION PACK, Model Number DYNJ38868L;  rr)\tPICC ACCESSORY TRAY, Model Number DYNJ39039M;  ss)\tCVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B;  tt)\tPICC INSERTION PACK MH-LF, Model Number DYNJ40206B;  uu)\tACCESS PICC PACK, Model Number DYNJ40682B;  vv)\tPHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C;  ww)\tMV-IR-PICC PACK-LF, Model Number DYNJ41554C;  xx)\tPICC TRAY, Model Number DYNJ41648;  yy)\tCENTRAL LINE TRAY, Model Number DYNJ42902C;  zz)\tCENTRAL LINE TRAY, Model Number DYNJ42902D;  aaa)\tVENOUS PACK, Model Number DYNJ43168;  bbb)\tVENOUS PACK, Model Number DYNJ43168A;  ccc)\tVENOUS PACK, Model Number DYNJ43168B;  ddd)\tIR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G;  eee)\tWEST VALLEY PICC LINE PACK, Model Number DYNJ43975A;  fff)\tVENOUS LIGATION PACK, Model Number DYNJ43981G;  ggg)\tVEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C;  hhh)\tVENOUS ABLATION, Model Number DYNJ44904C;  iii)\tPICC LINE PACK, Model Number DYNJ47037C;  jjj)\tPICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B;  kkk)\tCENTRAL LINE PACK, Model Number DYNJ48096B;  lll)\tPICC PACK-LF, Model Number DYNJ48120B;  mmm)\tAV FISTULA PACK-LF, Model Number DYNJ48428C;  nnn)\tVIEN CLOSURE, Model Number DYNJ49180A;  ooo)\tARTERIAL LINE PACK, Model Number DYNJ49235D;  ppp)\tPICC PACK, Model Number DYNJ52255;  qqq)\tPICC LINE TRAY, Model Number DYNJ52688B;  rrr)\tPICC LINE TRAY, Model Number DYNJ52688C;  sss)\tCENTRAL LINE INSERTION KIT, Model Number DYNJ52894A;  ttt)\tARTERIOGRAM PACK, Model Number DYNJ53095A;  uuu)\tENDOVENOUS ABLATION PACK, Model Number DYNJ53435D;  vvv)\tMID HUDSON PICC LINE PACK, Model Number DYNJ53618A;  www)\tMSB BEDSIDE TRAY, Model Number DYNJ54670;  xxx)\tLEE VEIN PACK, Model Number DYNJ54906C;  yyy)\tARTERIOGRAM PACK, Model Number DYNJ55169G;  zzz)\tPICC LINE PACK, Model Number DYNJ55170B;  aaaa)\tPICC LINE PACK, M (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-2167-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL BUNDLE NO CATHETER, Model Number ART995;  b)\tART LINE KIT NO CATH, Model Number ARTNC145;  c)\tCENTRAL LINE TRAY, Model Number CVI4705;  d)\tCENTRAL LINE INSERTION PACK, Model Number CVI4805;  e)\tED CENTRAL LINE KIT, Model Number CVI4865;  f)\tNO CATH MIDLINE INSERTION KIT, Model Number CVI4950A;  g)\tCENTRAL LINE PROCEDURE KIT, Model Number DT22260;  h)\tADULT EPIV INSERTION TRAY, Model Number DYNDA2482;  i)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669;  j)\tI.R. PICC PACK, Model Number DYNDA2759;  k)\tIR SONO PACK, Model Number DYNDA3010;  l)\tNEONATAL PICC LINE TRAY, Model Number DYNDC2120B;  m)\tPICC SUPPLEMENTAL KIT, Model Number DYNDC2373A;  n)\tCENTRAL LINE KIT, Model Number DYNDC2582A;  o)\tCENTRAL LINE KIT UTMB, Model Number DYNDC3061;  p)\tFNA TRAY, Model Number DYNDH1123B;  q)\tCVL PACK, Model Number DYNJ00281O;  r)\tCENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O;  s)\tCENTRAL LINE PACK-LF, Model Number DYNJ0220136Q;  t)\tPICC LINE PACK-LF, Model Number DYNJ0235859I;  u)\tPICC LINE PACK-LF, Model Number DYNJ0235859J;  v)\tPICC LINE PACK-LF, Model Number DYNJ0235859K;  w)\tPICC LINE PACK, Model Number DYNJ04592K;  x)\tPICC LINE PACK-LF, Model Number DYNJ0678523N;  y)\tPICC LINE PACK-LF, Model Number DYNJ0855123N;  z)\tPICC INSERTION PACK-LF, Model Number DYNJ0880659F;  aa)\tPICC PACK-LF, Model Number DYNJ0940720D;  bb)\tVENOUS ACCESS PACK-LF, Model Number DYNJ09895R;  cc)\tPICC PACK-LF, Model Number DYNJ17086A;  dd)\tVENOUS ACCESS TRAY, Model Number DYNJ20094L;  ee)\tPICC LINE PACK-LF, Model Number DYNJ21575I;  ff)\tCENTRAL LINE PACK, Model Number DYNJ30087C;  gg)\tPICC LINE PACK, Model Number DYNJ30233C;  hh)\tPICC PACK, Model Number DYNJ30566B;  ii)\tCENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G;  jj)\tPICC TRAY, Model Number DYNJ33005F;  kk)\tPICC TRAY, Model Number DYNJ33005G;  ll)\tPICC LINE INSERTION TRAY, Model Number DYNJ34241;  mm)\tPICC PACK-LF, Model Number DYNJ35000I;  nn)\tPORT PACK, Model Number DYNJ35163C;  oo)\tPICC TRAY-LF, Model Number DYNJ35272;  pp)\tPICC LINE INSERTION PACK, Model Number DYNJ38868K;  qq)\tPICC LINE INSERTION PACK, Model Number DYNJ38868L;  rr)\tPICC ACCESSORY TRAY, Model Number DYNJ39039M;  ss)\tCVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B;  tt)\tPICC INSERTION PACK MH-LF, Model Number DYNJ40206B;  uu)\tACCESS PICC PACK, Model Number DYNJ40682B;  vv)\tPHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C;  ww)\tMV-IR-PICC PACK-LF, Model Number DYNJ41554C;  xx)\tPICC TRAY, Model Number DYNJ41648;  yy)\tCENTRAL LINE TRAY, Model Number DYNJ42902C;  zz)\tCENTRAL LINE TRAY, Model Number DYNJ42902D;  aaa)\tVENOUS PACK, Model Number DYNJ43168;  bbb)\tVENOUS PACK, Model Number DYNJ43168A;  ccc)\tVENOUS PACK, Model Number DYNJ43168B;  ddd)\tIR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G;  eee)\tWEST VALLEY PICC LINE PACK, Model Number DYNJ43975A;  fff)\tVENOUS LIGATION PACK, Model Number DYNJ43981G;  ggg)\tVEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C;  hhh)\tVENOUS ABLATION, Model Number DYNJ44904C;  iii)\tPICC LINE PACK, Model Number DYNJ47037C;  jjj)\tPICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B;  kkk)\tCENTRAL LINE PACK, Model Number DYNJ48096B;  lll)\tPICC PACK-LF, Model Number DYNJ48120B;  mmm)\tAV FISTULA PACK-LF, Model Number DYNJ48428C;  nnn)\tVIEN CLOSURE, Model Number DYNJ49180A;  ooo)\tARTERIAL LINE PACK, Model Number DYNJ49235D;  ppp)\tPICC PACK, Model Number DYNJ52255;  qqq)\tPICC LINE TRAY, Model Number DYNJ52688B;  rrr)\tPICC LINE TRAY, Model Number DYNJ52688C;  sss)\tCENTRAL LINE INSERTION KIT, Model Number DYNJ52894A;  ttt)\tARTERIOGRAM PACK, Model Number DYNJ53095A;  uuu)\tENDOVENOUS ABLATION PACK, Model Number DYNJ53435D;  vvv)\tMID HUDSON PICC LINE PACK, Model Number DYNJ53618A;  www)\tMSB BEDSIDE TRAY, Model Number DYNJ54670;  xxx)\tLEE VEIN PACK, Model Number DYNJ54906C;  yyy)\tARTERIOGRAM PACK, Model Number DYNJ55169G;  zzz)\tPICC LINE PACK, Model Number DYNJ55170B;  aaaa)\tPICC LINE PACK, M",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2167-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2167-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL BUNDLE NO CATHETER, Model Number ART995;  b)\tART LINE KIT NO CATH, Model Number ARTNC145;  c)\tCENTRAL LINE TRAY, Model Number CVI4705;  d)\tCENTRAL LINE INSERTION PACK, Model Number CVI4805;  e)\tED CENTRAL LINE KIT, Model Number CVI4865;  f)\tNO CATH MIDLINE INSERTION KIT, Model Number CVI4950A;  g)\tCENTRAL LINE PROCEDURE KIT, Model Number DT22260;  h)\tADULT EPIV INSERTION TRAY, Model Number DYNDA2482;  i)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669;  j)\tI.R. PICC PACK, Model Number DYNDA2759;  k)\tIR SONO PACK, Model Number DYNDA3010;  l)\tNEONATAL PICC LINE TRAY, Model Number DYNDC2120B;  m)\tPICC SUPPLEMENTAL KIT, Model Number DYNDC2373A;  n)\tCENTRAL LINE KIT, Model Number DYNDC2582A;  o)\tCENTRAL LINE KIT UTMB, Model Number DYNDC3061;  p)\tFNA TRAY, Model Number DYNDH1123B;  q)\tCVL PACK, Model Number DYNJ00281O;  r)\tCENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O;  s)\tCENTRAL LINE PACK-LF, Model Number DYNJ0220136Q;  t)\tPICC LINE PACK-LF, Model Number DYNJ0235859I;  u)\tPICC LINE PACK-LF, Model Number DYNJ0235859J;  v)\tPICC LINE PACK-LF, Model Number DYNJ0235859K;  w)\tPICC LINE PACK, Model Number DYNJ04592K;  x)\tPICC LINE PACK-LF, Model Number DYNJ0678523N;  y)\tPICC LINE PACK-LF, Model Number DYNJ0855123N;  z)\tPICC INSERTION PACK-LF, Model Number DYNJ0880659F;  aa)\tPICC PACK-LF, Model Number DYNJ0940720D;  bb)\tVENOUS ACCESS PACK-LF, Model Number DYNJ09895R;  cc)\tPICC PACK-LF, Model Number DYNJ17086A;  dd)\tVENOUS ACCESS TRAY, Model Number DYNJ20094L;  ee)\tPICC LINE PACK-LF, Model Number DYNJ21575I;  ff)\tCENTRAL LINE PACK, Model Number DYNJ30087C;  gg)\tPICC LINE PACK, Model Number DYNJ30233C;  hh)\tPICC PACK, Model Number DYNJ30566B;  ii)\tCENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G;  jj)\tPICC TRAY, Model Number DYNJ33005F;  kk)\tPICC TRAY, Model Number DYNJ33005G;  ll)\tPICC LINE INSERTION TRAY, Model Number DYNJ34241;  mm)\tPICC PACK-LF, Model Number DYNJ35000I;  nn)\tPORT PACK, Model Number DYNJ35163C;  oo)\tPICC TRAY-LF, Model Number DYNJ35272;  pp)\tPICC LINE INSERTION PACK, Model Number DYNJ38868K;  qq)\tPICC LINE INSERTION PACK, Model Number DYNJ38868L;  rr)\tPICC ACCESSORY TRAY, Model Number DYNJ39039M;  ss)\tCVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B;  tt)\tPICC INSERTION PACK MH-LF, Model Number DYNJ40206B;  uu)\tACCESS PICC PACK, Model Number DYNJ40682B;  vv)\tPHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C;  ww)\tMV-IR-PICC PACK-LF, Model Number DYNJ41554C;  xx)\tPICC TRAY, Model Number DYNJ41648;  yy)\tCENTRAL LINE TRAY, Model Number DYNJ42902C;  zz)\tCENTRAL LINE TRAY, Model Number DYNJ42902D;  aaa)\tVENOUS PACK, Model Number DYNJ43168;  bbb)\tVENOUS PACK, Model Number DYNJ43168A;  ccc)\tVENOUS PACK, Model Number DYNJ43168B;  ddd)\tIR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G;  eee)\tWEST VALLEY PICC LINE PACK, Model Number DYNJ43975A;  fff)\tVENOUS LIGATION PACK, Model Number DYNJ43981G;  ggg)\tVEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C;  hhh)\tVENOUS ABLATION, Model Number DYNJ44904C;  iii)\tPICC LINE PACK, Model Number DYNJ47037C;  jjj)\tPICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B;  kkk)\tCENTRAL LINE PACK, Model Number DYNJ48096B;  lll)\tPICC PACK-LF, Model Number DYNJ48120B;  mmm)\tAV FISTULA PACK-LF, Model Number DYNJ48428C;  nnn)\tVIEN CLOSURE, Model Number DYNJ49180A;  ooo)\tARTERIAL LINE PACK, Model Number DYNJ49235D;  ppp)\tPICC PACK, Model Number DYNJ52255;  qqq)\tPICC LINE TRAY, Model Number DYNJ52688B;  rrr)\tPICC LINE TRAY, Model Number DYNJ52688C;  sss)\tCENTRAL LINE INSERTION KIT, Model Number DYNJ52894A;  ttt)\tARTERIOGRAM PACK, Model Number DYNJ53095A;  uuu)\tENDOVENOUS ABLATION PACK, Model Number DYNJ53435D;  vvv)\tMID HUDSON PICC LINE PACK, Model Number DYNJ53618A;  www)\tMSB BEDSIDE TRAY, Model Number DYNJ54670;  xxx)\tLEE VEIN PACK, Model Number DYNJ54906C;  yyy)\tARTERIOGRAM PACK, Model Number DYNJ55169G;  zzz)\tPICC LINE PACK, Model Number DYNJ55170B;  aaaa)\tPICC LINE PACK, M",
      "text": "The FDA logged enforcement record Z-2167-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tARTERIAL BUNDLE NO CATHETER, Model Number ART995;  b)\tART LINE KIT NO CATH, Model Number ARTNC145;  c)\tCENTRAL LINE TRAY, Model Number CVI4705;  d)\tCENTRAL LINE INSERTION PACK, Model Number CVI4805;  e)\tED CENTRAL LINE KIT, Model Number CVI4865;  f)\tNO CATH MIDLINE INSERTION KIT, Model Number CVI4950A;  g)\tCENTRAL LINE PROCEDURE KIT, Model Number DT22260;  h)\tADULT EPIV INSERTION TRAY, Model Number DYNDA2482;  i)\tULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669;  j)\tI.R. PICC PACK, Model Number DYNDA2759;  k)\tIR SONO PACK, Model Number DYNDA3010;  l)\tNEONATAL PICC LINE TRAY, Model Number DYNDC2120B;  m)\tPICC SUPPLEMENTAL KIT, Model Number DYNDC2373A;  n)\tCENTRAL LINE KIT, Model Number DYNDC2582A;  o)\tCENTRAL LINE KIT UTMB, Model Number DYNDC3061;  p)\tFNA TRAY, Model Number DYNDH1123B;  q)\tCVL PACK, Model Number DYNJ00281O;  r)\tCENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O;  s)\tCENTRAL LINE PACK-LF, Model Number DYNJ0220136Q;  t)\tPICC LINE PACK-LF, Model Number DYNJ0235859I;  u)\tPICC LINE PACK-LF, Model Number DYNJ0235859J;  v)\tPICC LINE PACK-LF, Model Number DYNJ0235859K;  w)\tPICC LINE PACK, Model Number DYNJ04592K;  x)\tPICC LINE PACK-LF, Model Number DYNJ0678523N;  y)\tPICC LINE PACK-LF, Model Number DYNJ0855123N;  z)\tPICC INSERTION PACK-LF, Model Number DYNJ0880659F;  aa)\tPICC PACK-LF, Model Number DYNJ0940720D;  bb)\tVENOUS ACCESS PACK-LF, Model Number DYNJ09895R;  cc)\tPICC PACK-LF, Model Number DYNJ17086A;  dd)\tVENOUS ACCESS TRAY, Model Number DYNJ20094L;  ee)\tPICC LINE PACK-LF, Model Number DYNJ21575I;  ff)\tCENTRAL LINE PACK, Model Number DYNJ30087C;  gg)\tPICC LINE PACK, Model Number DYNJ30233C;  hh)\tPICC PACK, Model Number DYNJ30566B;  ii)\tCENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G;  jj)\tPICC TRAY, Model Number DYNJ33005F;  kk)\tPICC TRAY, Model Number DYNJ33005G;  ll)\tPICC LINE INSERTION TRAY, Model Number DYNJ34241;  mm)\tPICC PACK-LF, Model Number DYNJ35000I;  nn)\tPORT PACK, Model Number DYNJ35163C;  oo)\tPICC TRAY-LF, Model Number DYNJ35272;  pp)\tPICC LINE INSERTION PACK, Model Number DYNJ38868K;  qq)\tPICC LINE INSERTION PACK, Model Number DYNJ38868L;  rr)\tPICC ACCESSORY TRAY, Model Number DYNJ39039M;  ss)\tCVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B;  tt)\tPICC INSERTION PACK MH-LF, Model Number DYNJ40206B;  uu)\tACCESS PICC PACK, Model Number DYNJ40682B;  vv)\tPHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C;  ww)\tMV-IR-PICC PACK-LF, Model Number DYNJ41554C;  xx)\tPICC TRAY, Model Number DYNJ41648;  yy)\tCENTRAL LINE TRAY, Model Number DYNJ42902C;  zz)\tCENTRAL LINE TRAY, Model Number DYNJ42902D;  aaa)\tVENOUS PACK, Model Number DYNJ43168;  bbb)\tVENOUS PACK, Model Number DYNJ43168A;  ccc)\tVENOUS PACK, Model Number DYNJ43168B;  ddd)\tIR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G;  eee)\tWEST VALLEY PICC LINE PACK, Model Number DYNJ43975A;  fff)\tVENOUS LIGATION PACK, Model Number DYNJ43981G;  ggg)\tVEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C;  hhh)\tVENOUS ABLATION, Model Number DYNJ44904C;  iii)\tPICC LINE PACK, Model Number DYNJ47037C;  jjj)\tPICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B;  kkk)\tCENTRAL LINE PACK, Model Number DYNJ48096B;  lll)\tPICC PACK-LF, Model Number DYNJ48120B;  mmm)\tAV FISTULA PACK-LF, Model Number DYNJ48428C;  nnn)\tVIEN CLOSURE, Model Number DYNJ49180A;  ooo)\tARTERIAL LINE PACK, Model Number DYNJ49235D;  ppp)\tPICC PACK, Model Number DYNJ52255;  qqq)\tPICC LINE TRAY, Model Number DYNJ52688B;  rrr)\tPICC LINE TRAY, Model Number DYNJ52688C;  sss)\tCENTRAL LINE INSERTION KIT, Model Number DYNJ52894A;  ttt)\tARTERIOGRAM PACK, Model Number DYNJ53095A;  uuu)\tENDOVENOUS ABLATION PACK, Model Number DYNJ53435D;  vvv)\tMID HUDSON PICC LINE PACK, Model Number DYNJ53618A;  www)\tMSB BEDSIDE TRAY, Model Number DYNJ54670;  xxx)\tLEE VEIN PACK, Model Number DYNJ54906C;  yyy)\tARTERIOGRAM PACK, Model Number DYNJ55169G;  zzz)\tPICC LINE PACK, Model Number DYNJ55170B;  aaaa)\tPICC LINE PACK, M — 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 ART995, UDI/DI (EA) 10193489190502,UDI/DI (CS) 40193489190503;  b) Model Number ARTNC145, UDI/DI (EA) 10195327306762,UDI/DI (CS) 40195327306763;  c) Model Number CVI4705, UDI/DI (EA) 10193489832372,UDI/DI (CS) 40193489832373;  d) Model Number CVI4805, UDI/DI (EA) 10195327068714,UDI/DI (CS) 40195327068715;  e) Model Number CVI4865, UDI/DI (EA) 10195327235260,UDI/DI (CS) 40195327235261;  f) Model Number CVI4950A, UDI/DI (EA) 10195327351960,UDI/DI (CS) 40195327351961;  g) Model Number DT22260, UDI/DI (EA) 10653160329190,UDI/DI (CS) 40653160329191;  h) Model Number DYNDA2482, UDI/DI (EA) 10193489351606,UDI/DI (CS) 40193489351607;  i) Model Number DYNDA2669, UDI/DI (EA) 10193489465426,UDI/DI (CS) 40193489465427;  j) Model Number DYNDA2759, UDI/DI (EA) 10193489488197,UDI/DI (CS) 40193489488198;  k) Model Number DYNDA3010, UDI/DI (EA) 10195327282301,UDI/DI (CS) 40195327282302;  l) Model Number DYNDC2120B, UDI/DI (EA) 10193489363357,UDI/DI (CS) 40193489363358;  m) Model Number DYNDC2373A, UDI/DI (EA) 10889942492206,UDI/DI (CS) 40889942492207;  n) Model Number DYNDC2582A, UDI/DI (EA) 10193489349399,UDI/DI (CS) 40193489349390;  o) Model Number DYNDC3061, UDI/DI (EA) 10193489495812,UDI/DI (CS) 40193489495813;  p) Model Number DYNDH1123B, UDI/DI (EA) 10193489465556,UDI/DI (CS) 40193489465557;  q) Model Number DYNJ00281O, UDI/DI (EA) 10193489962963,UDI/DI (CS) 40193489962964;  r) Model Number DYNJ0214541O, UDI/DI (EA) 10195327088880,UDI/DI (CS) 40195327088881;  s) Model Number DYNJ0220136Q, UDI/DI (EA) 10193489823486,UDI/DI (CS) 40193489823487;  t) Model Number DYNJ0235859I, UDI/DI (EA) 10193489421347,UDI/DI (CS) 40193489421348;  u) Model Number DYNJ0235859J, UDI/DI (EA) 10195327069278,UDI/DI (CS) 40195327069279;  v) Model Number DYNJ0235859K, UDI/DI (EA) 10195327243210,UDI/DI (CS) 40195327243211;  w) Model Number DYNJ04592K, UDI/DI (EA) 10193489215205,UDI/DI (CS) 40193489215206;  x) Model Number DYNJ0678523N, UDI/DI (EA) 10193489994049,UDI/DI (CS) 40193489994040;  y) Model Number DYNJ0855123N, UDI/DI (EA) 10195327094881,UDI/DI (CS) 40195327094882;  z) Model Number DYNJ0880659F, UDI/DI (EA) 10195327111496,UDI/DI (CS) 40195327111497;  aa) Model Number DYNJ0940720D, UDI/DI (EA) 10889942550951,UDI/DI (CS) 40889942550952;  bb) Model Number DYNJ09895R, UDI/DI (EA) 10195327264529,UDI/DI (CS) 40195327264520;  cc) Model Number DYNJ17086A, UDI/DI (EA) 10884389064306,UDI/DI (CS) 40884389064307;  dd) Model Number DYNJ20094L, UDI/DI (EA) 10195327212902,UDI/DI (CS) 40195327212903;  ee) Model Number DYNJ21575I, UDI/DI (EA) 10195327009670,UDI/DI (CS) 40195327009671;  ff) Model Number DYNJ30087C, UDI/DI (EA) 10889942754144,UDI/DI (CS) 40889942754145;  gg) Model Number DYNJ30233C, UDI/DI (EA) 10193489382570,UDI/DI (CS) 40193489382571;  hh) Model Number DYNJ30566B, UDI/DI (EA) 10889942375523,UDI/DI (CS) 40889942375524;  ii) Model Number DYNJ32358G, UDI/DI (EA) 10889942526475,UDI/DI (CS) 40889942526476;  jj) Model Number DYNJ33005F, UDI/DI (EA) 10193489954135,UDI/DI (CS) 40193489954136;  kk) Model Number DYNJ33005G, UDI/DI (EA) 10195327319663,UDI/DI (CS) 40195327319664;  ll) Model Number DYNJ34241, UDI/DI (EA) 10884389335864,UDI/DI (CS) 40884389335865;  mm) Model Number DYNJ35000I, UDI/DI (EA) 10193489261646,UDI/DI (CS) 40193489261647;  nn) Model Number DYNJ35163C, UDI/DI (EA) 10889942494682,UDI/DI (CS) 40889942494683;  oo) Model Number DYNJ35272, UDI/DI (EA) 10884389428269,UDI/DI (CS) 40884389428260;  pp) Model Number DYNJ38868K, UDI/DI (EA) 10193489657609,UDI/DI (CS) 40193489657600;  qq) Model Number DYNJ38868L, UDI/DI (EA) 10195327224776,UDI/DI (CS) 40195327224777;  rr) Model Number DYNJ39039M, UDI/DI (EA) 10193489898507,UDI/DI (CS) 40193489898508;  ss) Model Number DYNJ40204B, UDI/DI (EA) 10195327178451,UDI/DI (CS) 40195327178452;  tt) Model Number DYNJ40206B, UDI/DI (EA) 10195327176440,UDI/DI (CS) 40195327176441;  uu) Model Number DYNJ40682B, UDI/DI (EA) 10889942267217,UDI/DI (CS) 40889942267218;  vv) Model Number DYNJ40990C, UDI/DI (EA) 10889942024377,UDI/DI (CS) 40889942024378;  ww) Model Number DYNJ41554C, UDI/DI (EA) 10889942811328,UDI/DI (CS) 40889942811329;  xx) Model Number DYNJ41648, UDI/DI (EA) 10884389909171,UDI/DI (CS) 40884389909172;  yy) Model Number DYNJ42902C, UDI/DI (EA) 10195327084684,UDI/DI (CS) 40195327084685;  zz) Model Number DYNJ42902D, UDI/DI (EA) 10195327171100,UDI/DI (CS) 40195327171101;  aaa) Model Number DYNJ43168, UDI/DI (EA) 10888277034891,UDI/DI (CS) 40888277034892;  bbb) Model Number DYNJ43168A, UDI/DI (EA) 10195327084707,UDI/DI (CS) 40195327084708;  ccc) Model Number DYNJ43168B, UDI/DI (EA) 10195327224523,UDI/DI (CS) 40195327224524;  ddd) Model Number DYNJ43267G, UDI/DI (EA) 10195327288808,UDI/DI (CS) 40195327288809;  eee) Model Number DYNJ43975A, UDI/DI (EA) 10888277882447,UDI/DI (CS) 40888277882448;  fff) Model Number DYNJ43981G, UDI/DI (EA) 10193489223538,UDI/DI (CS) 40193489223539;  ggg) Model Number DYNJ44737C, UDI/DI (EA) 10195327277871,UDI/DI (CS) 40195327277872;  hhh) Model Number DYNJ44904C, UDI/DI (EA) 10193489858679,UDI/DI (CS) 40193489858670;  iii) Model Number DYNJ47037C, UDI/DI (EA) 10193489616002,UDI/DI (CS) 40193489616003;  jjj) Model Number DYNJ47717B, UDI/DI (EA) 10195327355302,UDI/DI (CS) 40195327355303;  kkk) Model Number DYNJ48096B, UDI/DI (EA) 10888277939318,UDI/DI (CS) 40888277939319;  lll) Model Number DYNJ48120B, UDI/DI (EA) 10888277894877,UDI/DI (CS) 40888277894878;  mmm) Model Number DYNJ48428C, UDI/DI (EA) 10193489702477,UDI/DI (CS) 40193489702478;  nnn) Model Number DYNJ49180A, UDI/DI (EA) 10888277863569,UDI/DI (CS) 40888277863560;  ooo) Model Number DYNJ49235D, UDI/DI (EA) 10193489894332,UDI/DI (CS) 40193489894333;  ppp) Model Number DYNJ52255, UDI/DI (EA) 10889942253708,UDI/DI (CS) 40889942253709;  qqq) Model Number DYNJ52688B, UDI/DI (EA) 10193489452471,UDI/DI (CS) 40193489452472;  rrr) Model Number DYNJ52688C, UDI/DI (EA) 10195327301026,UDI/DI (CS) 40195327301027;  sss) Model Number DYNJ52894A, UDI/DI (EA) 10889942437542,UDI/DI (CS) 40889942437543;  ttt) Model Number DYNJ53095A, UDI/DI (EA) 10195327148720,UDI/DI (CS) 40195327148721;  uuu) Model Number DYNJ53435D, UDI/DI (EA) 10195327196448,UDI/DI (CS) 40195327196449;  vvv) Model Number DYNJ53618A, UDI/DI (EA) 10889942492497,UDI/DI (CS) 40889942492498;  www) Model Number DYNJ54670, UDI/DI (EA) 10889942499571,UDI/DI (CS) 40889942499572;  xxx) Model Number DYNJ54906C, UDI/DI (EA) 10195327188764,UDI/DI (CS) 40195327188765;  yyy) Model Number DYNJ55169G, UDI/DI (EA) 10193489967562,UDI/DI (CS) 40193489967563;  zzz) Model Number DYNJ55170B, UDI/DI (EA) 10193489967579,UDI/DI (CS) 40193489967570;  aaaa) Model Number DYNJ55170C, UDI/DI (EA) 10195327135355,UDI/DI (CS) 40195327135356;  bbbb) Model Number DYNJ55546D, UDI/DI (EA) 10195327056520,UDI/DI (CS) 40195327056521;  cccc) Model Number DYNJ56029A, UDI/DI (EA) 10195327347826,UDI/DI (CS) 40195327347827;  dddd) Model Number DYNJ56857C, UDI/DI (EA) 10193489967586,UDI/DI (CS) 40193489967587;  eeee) Model Number DYNJ56857D, UDI/DI (EA) 10195327280963,UDI/DI (CS) 40195327280964;  ffff) Model Number DYNJ57112, UDI/DI (EA) 10889942721597,UDI/DI (CS) 40889942721598;  gggg) Model Number DYNJ57793A, UDI/DI (EA) 10193489846027,UDI/DI (CS) 40193489846028;  hhhh) Model Number DYNJ59246A, UDI/DI (EA) 10195327039110,UDI/DI (CS) 40195327039111;  iiii) Model Number DYNJ59751B, UDI/DI (EA) 10193489695915,UDI/DI (CS) 40193489695916;  jjjj) Model Number DYNJ60038A, UDI/DI (EA) 10195327038335,UDI/DI (CS) 40195327038336;  kkkk) Model Number DYNJ60329A, UDI/DI (EA) 10193489972221,UDI/DI (CS) 40193489972222;  llll) Model Number DYNJ60990B, UDI/DI (EA) 10193489921700,UDI/DI (CS) 40193489921701;  mmmm) Model Number DYNJ62038B, UDI/DI (EA) 10193489898491,UDI/DI (CS) 40193489898492;  nnnn) Model Number DYNJ62711A, UDI/DI (EA) 10193489233018,UDI/DI (CS) 40193489233019;  oooo) Model Number DYNJ62889A, UDI/DI (EA) 10193489971125,UDI/DI (CS) 40193489971126;  pppp) Model Number DYNJ62889B, UDI/DI (EA) 10195327030957,UDI/DI (CS) 40195327030958;  qqqq) Model Number DYNJ63162, UDI/DI (EA) 10193489720891,UDI/DI (CS) 40193489720892;  rrrr) Model Number DYNJ63213, UDI/DI (EA) 10193489728217,UDI/DI (CS) 40193489728218;  ssss) Model Number DYNJ63268C, UDI/DI (EA) 10195327077167,UDI/DI (CS) 40195327077168;  tttt) Model Number DYNJ63268D, UDI/DI (EA) 10195327132217,UDI/DI (CS) 40195327132218;  uuuu) Model Number DYNJ63268F, UDI/DI (EA) 10195327297114,UDI/DI (CS) 40195327297115;  vvvv) Model Number DYNJ63590, UDI/DI (EA) 10193489769180,UDI/DI (CS) 40193489769181;  wwww) Model Number DYNJ64141A, UDI/DI (EA) 10195327279578,UDI/DI (CS) 40195327279579;  xxxx) Model Number DYNJ64190B, UDI/DI (EA) 10195327281281,UDI/DI (CS) 40195327281282;  yyyy) Model Number DYNJ64249A, UDI/DI (EA) 10193489381368,UDI/DI (CS) 40193489381369;  zzzz) Model Number DYNJ64337, UDI/DI (EA) 10193489800289,UDI/DI (CS) 40193489800280;. 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-2167-2023&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-2167-2023&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-2167-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2167-2023 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-2167-2023&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-2167-2023&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-2167-2023/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-2167-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2167-2023",
            "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",
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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"
          }
        }
      ]
    }
  ]
}