{
  "@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-2160-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;  b)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)\tANGIOGRAM, Model Number DYNJ0149444N;  e)\tDIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)\tPICC LINE PACK-LF, Model Number DYNJ0275614F;  g)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)\tANGIO PACK-LF, Model Number DYNJ0407399P;  l)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)\tVISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)\tCARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)\tLT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)\tCATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA;  r)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R;  s)\tCARDIAC CATH PACK-LF, Model Number DYNJ0842644F;  t)\tPEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K;  u)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V;  v)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138P;  w)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138Q;  x)\tIR PICC PACK-LF, Model Number DYNJ0950839C;  y)\tSPECIAL PROCEDURES, Model Number DYNJ23288C;  z)\tANGIO TRAY, Model Number DYNJ23438M;  aa)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455K;  bb)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455L;  cc)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455M;  dd)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455N;  ee)\tSTENT PACK-LF, Model Number DYNJ27613K;  ff)\tCATH I W/ ANGIO DRAPE, Model Number DYNJ33709F;  gg)\tJUGULAR PACK, Model Number DYNJ35164C;  hh)\tANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F;  ii)\tANGIO DRAPE II-LF, Model Number DYNJ35994C;  jj)\tANGIO/PICC PACK, Model Number DYNJ36049A;  kk)\tISSAQUA CATH/IR PACK, Model Number DYNJ36738G;  ll)\tIR PACK, Model Number DYNJ36752B;  mm)\tARTERIOGRAM TRAY-LF, Model Number DYNJ36807C;  nn)\tSPECIAL PROCEDURE PACK, Model Number DYNJ38314G;  oo)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G;  pp)\tCARDIAC CATH PACK, Model Number DYNJ38866F;  qq)\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B;  rr)\tABLATION PACK, Model Number DYNJ40629C;  ss)\tCATH LAB PACK, Model Number DYNJ40926A;  tt)\tRADIOLOGY PACK, Model Number DYNJ41190;  uu)\tTV IR PACK-LF, Model Number DYNJ41562F;  vv)\tCUSTOM ANGIO TRAY, Model Number DYNJ41649G;  ww)\tCARDIAC CATH DRAPE PACK, Model Number DYNJ41700A;  xx)\tIR PACK, Model Number DYNJ41989G;  yy)\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C;  zz)\tANGIO PACK, Model Number DYNJ42903C;  aaa)\tANGIO PACK, Model Number DYNJ42903D;  bbb)\tCARDIAC CATH PACK-LF, Model Number DYNJ42996C;  ccc)\tDIALYSIS TRAY, Model Number DYNJ43060B;  ddd)\tANGIOPLASTY PACK-LF, Model Number DYNJ43203G;  eee)\tARTERIOGRAM PACK, Model Number DYNJ43261J;  fff)\tCATH LAB RIGHT HEART PACK, Model Number DYNJ43315L;  ggg)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609P;  hhh)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609R;  iii)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609S;  jjj)\tANGIO PACK, Model Number DYNJ43661C;  kkk)\tABLATION EP PACK, Model Number DYNJ43851B;  lll)\tPK, RADIOLOGY, Model Number DYNJ43894B;  mmm)\tPK, RADIOLOGY, Model Number DYNJ44087A;  nnn)\tANGIOGRAPHY PACK, Model Number DYNJ44293F;  ooo)\tANGIO DRAPE PACK, Model Number DYNJ44320G;  ppp)\tANGIO DRAPE PACK, Model Number DYNJ44320I;  qqq)\tANGIO DRAPE PACK, Model Number DYNJ44320J;  rrr)\tFEMORAL ANGIO PACK, Model Number DYNJ44334M;  sss)\tFEMORAL ANGIO PACK, Model Number DYNJ44334N;  ttt)\tRADIOLOGY PACK, Model Number DYNJ44524F;  uuu)\tANGIO PACK, Model Number DYNJ44642B;  vvv)\tANGIOPLASTY PACK, Model Number DYNJ44700J;  www)\tANGIO PACK, Model Number DYNJ44993J;  xxx)\tANGIOGRAPHY PACK, Model Number DYNJ45059B;  yyy)\tPERCUTANEOUS PACK, Model Number D",
  "description": "FDA recall Z-2160-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;  b)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)\tANGIOGRAM, Model Number DYNJ0149444N;  e)\tDIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)\tPICC LINE PACK-LF, Model Number DYNJ0275614F;  g)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)\tANGIO PACK-LF, Model Number DYNJ0407399P;  l)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)\tVISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)\tCARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)\tLT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)\tCATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA;  r)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R;  s)\tCARDIAC CATH PACK-LF, Model Number DYNJ0842644F;  t)\tPEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K;  u)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V;  v)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138P;  w)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138Q;  x)\tIR PICC PACK-LF, Model Number DYNJ0950839C;  y)\tSPECIAL PROCEDURES, Model Number DYNJ23288C;  z)\tANGIO TRAY, Model Number DYNJ23438M;  aa)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455K;  bb)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455L;  cc)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455M;  dd)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455N;  ee)\tSTENT PACK-LF, Model Number DYNJ27613K;  ff)\tCATH I W/ ANGIO DRAPE, Model Number DYNJ33709F;  gg)\tJUGULAR PACK, Model Number DYNJ35164C;  hh)\tANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F;  ii)\tANGIO DRAPE II-LF, Model Number DYNJ35994C;  jj)\tANGIO/PICC PACK, Model Number DYNJ36049A;  kk)\tISSAQUA CATH/IR PACK, Model Number DYNJ36738G;  ll)\tIR PACK, Model Number DYNJ36752B;  mm)\tARTERIOGRAM TRAY-LF, Model Number DYNJ36807C;  nn)\tSPECIAL PROCEDURE PACK, Model Number DYNJ38314G;  oo)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G;  pp)\tCARDIAC CATH PACK, Model Number DYNJ38866F;  qq)\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B;  rr)\tABLATION PACK, Model Number DYNJ40629C;  ss)\tCATH LAB PACK, Model Number DYNJ40926A;  tt)\tRADIOLOGY PACK, Model Number DYNJ41190;  uu)\tTV IR PACK-LF, Model Number DYNJ41562F;  vv)\tCUSTOM ANGIO TRAY, Model Number DYNJ41649G;  ww)\tCARDIAC CATH DRAPE PACK, Model Number DYNJ41700A;  xx)\tIR PACK, Model Number DYNJ41989G;  yy)\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C;  zz)\tANGIO PACK, Model Number DYNJ42903C;  aaa)\tANGIO PACK, Model Number DYNJ42903D;  bbb)\tCARDIAC CATH PACK-LF, Model Number DYNJ42996C;  ccc)\tDIALYSIS TRAY, Model Number DYNJ43060B;  ddd)\tANGIOPLASTY PACK-LF, Model Number DYNJ43203G;  eee)\tARTERIOGRAM PACK, Model Number DYNJ43261J;  fff)\tCATH LAB RIGHT HEART PACK, Model Number DYNJ43315L;  ggg)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609P;  hhh)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609R;  iii)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609S;  jjj)\tANGIO PACK, Model Number DYNJ43661C;  kkk)\tABLATION EP PACK, Model Number DYNJ43851B;  lll)\tPK, RADIOLOGY, Model Number DYNJ43894B;  mmm)\tPK, RADIOLOGY, Model Number DYNJ44087A;  nnn)\tANGIOGRAPHY PACK, Model Number DYNJ44293F;  ooo)\tANGIO DRAPE PACK, Model Number DYNJ44320G;  ppp)\tANGIO DRAPE PACK, Model Number DYNJ44320I;  qqq)\tANGIO DRAPE PACK, Model Number DYNJ44320J;  rrr)\tFEMORAL ANGIO PACK, Model Number DYNJ44334M;  sss)\tFEMORAL ANGIO PACK, Model Number DYNJ44334N;  ttt)\tRADIOLOGY PACK, Model Number DYNJ44524F;  uuu)\tANGIO PACK, Model Number DYNJ44642B;  vvv)\tANGIOPLASTY PACK, Model Number DYNJ44700J;  www)\tANGIO PACK, Model Number DYNJ44993J;  xxx)\tANGIOGRAPHY PACK, Model Number DYNJ45059B;  yyy)\tPERCUTANEOUS PACK, Model Number D (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-2160-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;  b)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)\tANGIOGRAM, Model Number DYNJ0149444N;  e)\tDIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)\tPICC LINE PACK-LF, Model Number DYNJ0275614F;  g)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)\tANGIO PACK-LF, Model Number DYNJ0407399P;  l)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)\tVISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)\tCARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)\tLT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)\tCATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA;  r)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R;  s)\tCARDIAC CATH PACK-LF, Model Number DYNJ0842644F;  t)\tPEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K;  u)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V;  v)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138P;  w)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138Q;  x)\tIR PICC PACK-LF, Model Number DYNJ0950839C;  y)\tSPECIAL PROCEDURES, Model Number DYNJ23288C;  z)\tANGIO TRAY, Model Number DYNJ23438M;  aa)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455K;  bb)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455L;  cc)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455M;  dd)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455N;  ee)\tSTENT PACK-LF, Model Number DYNJ27613K;  ff)\tCATH I W/ ANGIO DRAPE, Model Number DYNJ33709F;  gg)\tJUGULAR PACK, Model Number DYNJ35164C;  hh)\tANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F;  ii)\tANGIO DRAPE II-LF, Model Number DYNJ35994C;  jj)\tANGIO/PICC PACK, Model Number DYNJ36049A;  kk)\tISSAQUA CATH/IR PACK, Model Number DYNJ36738G;  ll)\tIR PACK, Model Number DYNJ36752B;  mm)\tARTERIOGRAM TRAY-LF, Model Number DYNJ36807C;  nn)\tSPECIAL PROCEDURE PACK, Model Number DYNJ38314G;  oo)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G;  pp)\tCARDIAC CATH PACK, Model Number DYNJ38866F;  qq)\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B;  rr)\tABLATION PACK, Model Number DYNJ40629C;  ss)\tCATH LAB PACK, Model Number DYNJ40926A;  tt)\tRADIOLOGY PACK, Model Number DYNJ41190;  uu)\tTV IR PACK-LF, Model Number DYNJ41562F;  vv)\tCUSTOM ANGIO TRAY, Model Number DYNJ41649G;  ww)\tCARDIAC CATH DRAPE PACK, Model Number DYNJ41700A;  xx)\tIR PACK, Model Number DYNJ41989G;  yy)\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C;  zz)\tANGIO PACK, Model Number DYNJ42903C;  aaa)\tANGIO PACK, Model Number DYNJ42903D;  bbb)\tCARDIAC CATH PACK-LF, Model Number DYNJ42996C;  ccc)\tDIALYSIS TRAY, Model Number DYNJ43060B;  ddd)\tANGIOPLASTY PACK-LF, Model Number DYNJ43203G;  eee)\tARTERIOGRAM PACK, Model Number DYNJ43261J;  fff)\tCATH LAB RIGHT HEART PACK, Model Number DYNJ43315L;  ggg)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609P;  hhh)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609R;  iii)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609S;  jjj)\tANGIO PACK, Model Number DYNJ43661C;  kkk)\tABLATION EP PACK, Model Number DYNJ43851B;  lll)\tPK, RADIOLOGY, Model Number DYNJ43894B;  mmm)\tPK, RADIOLOGY, Model Number DYNJ44087A;  nnn)\tANGIOGRAPHY PACK, Model Number DYNJ44293F;  ooo)\tANGIO DRAPE PACK, Model Number DYNJ44320G;  ppp)\tANGIO DRAPE PACK, Model Number DYNJ44320I;  qqq)\tANGIO DRAPE PACK, Model Number DYNJ44320J;  rrr)\tFEMORAL ANGIO PACK, Model Number DYNJ44334M;  sss)\tFEMORAL ANGIO PACK, Model Number DYNJ44334N;  ttt)\tRADIOLOGY PACK, Model Number DYNJ44524F;  uuu)\tANGIO PACK, Model Number DYNJ44642B;  vvv)\tANGIOPLASTY PACK, Model Number DYNJ44700J;  www)\tANGIO PACK, Model Number DYNJ44993J;  xxx)\tANGIOGRAPHY PACK, Model Number DYNJ45059B;  yyy)\tPERCUTANEOUS PACK, Model Number D",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2160-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2160-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;  b)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)\tANGIOGRAM, Model Number DYNJ0149444N;  e)\tDIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)\tPICC LINE PACK-LF, Model Number DYNJ0275614F;  g)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)\tANGIO PACK-LF, Model Number DYNJ0407399P;  l)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)\tVISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)\tCARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)\tLT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)\tCATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA;  r)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R;  s)\tCARDIAC CATH PACK-LF, Model Number DYNJ0842644F;  t)\tPEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K;  u)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V;  v)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138P;  w)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138Q;  x)\tIR PICC PACK-LF, Model Number DYNJ0950839C;  y)\tSPECIAL PROCEDURES, Model Number DYNJ23288C;  z)\tANGIO TRAY, Model Number DYNJ23438M;  aa)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455K;  bb)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455L;  cc)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455M;  dd)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455N;  ee)\tSTENT PACK-LF, Model Number DYNJ27613K;  ff)\tCATH I W/ ANGIO DRAPE, Model Number DYNJ33709F;  gg)\tJUGULAR PACK, Model Number DYNJ35164C;  hh)\tANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F;  ii)\tANGIO DRAPE II-LF, Model Number DYNJ35994C;  jj)\tANGIO/PICC PACK, Model Number DYNJ36049A;  kk)\tISSAQUA CATH/IR PACK, Model Number DYNJ36738G;  ll)\tIR PACK, Model Number DYNJ36752B;  mm)\tARTERIOGRAM TRAY-LF, Model Number DYNJ36807C;  nn)\tSPECIAL PROCEDURE PACK, Model Number DYNJ38314G;  oo)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G;  pp)\tCARDIAC CATH PACK, Model Number DYNJ38866F;  qq)\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B;  rr)\tABLATION PACK, Model Number DYNJ40629C;  ss)\tCATH LAB PACK, Model Number DYNJ40926A;  tt)\tRADIOLOGY PACK, Model Number DYNJ41190;  uu)\tTV IR PACK-LF, Model Number DYNJ41562F;  vv)\tCUSTOM ANGIO TRAY, Model Number DYNJ41649G;  ww)\tCARDIAC CATH DRAPE PACK, Model Number DYNJ41700A;  xx)\tIR PACK, Model Number DYNJ41989G;  yy)\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C;  zz)\tANGIO PACK, Model Number DYNJ42903C;  aaa)\tANGIO PACK, Model Number DYNJ42903D;  bbb)\tCARDIAC CATH PACK-LF, Model Number DYNJ42996C;  ccc)\tDIALYSIS TRAY, Model Number DYNJ43060B;  ddd)\tANGIOPLASTY PACK-LF, Model Number DYNJ43203G;  eee)\tARTERIOGRAM PACK, Model Number DYNJ43261J;  fff)\tCATH LAB RIGHT HEART PACK, Model Number DYNJ43315L;  ggg)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609P;  hhh)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609R;  iii)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609S;  jjj)\tANGIO PACK, Model Number DYNJ43661C;  kkk)\tABLATION EP PACK, Model Number DYNJ43851B;  lll)\tPK, RADIOLOGY, Model Number DYNJ43894B;  mmm)\tPK, RADIOLOGY, Model Number DYNJ44087A;  nnn)\tANGIOGRAPHY PACK, Model Number DYNJ44293F;  ooo)\tANGIO DRAPE PACK, Model Number DYNJ44320G;  ppp)\tANGIO DRAPE PACK, Model Number DYNJ44320I;  qqq)\tANGIO DRAPE PACK, Model Number DYNJ44320J;  rrr)\tFEMORAL ANGIO PACK, Model Number DYNJ44334M;  sss)\tFEMORAL ANGIO PACK, Model Number DYNJ44334N;  ttt)\tRADIOLOGY PACK, Model Number DYNJ44524F;  uuu)\tANGIO PACK, Model Number DYNJ44642B;  vvv)\tANGIOPLASTY PACK, Model Number DYNJ44700J;  www)\tANGIO PACK, Model Number DYNJ44993J;  xxx)\tANGIOGRAPHY PACK, Model Number DYNJ45059B;  yyy)\tPERCUTANEOUS PACK, Model Number D",
      "text": "The FDA logged enforcement record Z-2160-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tANGIOGRAPHY DRAPE PACK, Model Number 00-400305R;  b)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C;  c)\tANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D;  d)\tANGIOGRAM, Model Number DYNJ0149444N;  e)\tDIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G;  f)\tPICC LINE PACK-LF, Model Number DYNJ0275614F;  g)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M;  h)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V;  i)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W;  j)\tANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X;  k)\tANGIO PACK-LF, Model Number DYNJ0407399P;  l)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA;  m)\tVISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K;  n)\tCARDIAC EP PACK-LF, Model Number DYNJ0429185L;  o)\tSPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C;  p)\tLT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG;  q)\tCATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA;  r)\tSPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R;  s)\tCARDIAC CATH PACK-LF, Model Number DYNJ0842644F;  t)\tPEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K;  u)\tANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V;  v)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138P;  w)\tCARDIAC CATH PACK-LF, Model Number DYNJ0855138Q;  x)\tIR PICC PACK-LF, Model Number DYNJ0950839C;  y)\tSPECIAL PROCEDURES, Model Number DYNJ23288C;  z)\tANGIO TRAY, Model Number DYNJ23438M;  aa)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455K;  bb)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455L;  cc)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455M;  dd)\tADULT CARDIAC CATH PACK, Model Number DYNJ23455N;  ee)\tSTENT PACK-LF, Model Number DYNJ27613K;  ff)\tCATH I W/ ANGIO DRAPE, Model Number DYNJ33709F;  gg)\tJUGULAR PACK, Model Number DYNJ35164C;  hh)\tANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F;  ii)\tANGIO DRAPE II-LF, Model Number DYNJ35994C;  jj)\tANGIO/PICC PACK, Model Number DYNJ36049A;  kk)\tISSAQUA CATH/IR PACK, Model Number DYNJ36738G;  ll)\tIR PACK, Model Number DYNJ36752B;  mm)\tARTERIOGRAM TRAY-LF, Model Number DYNJ36807C;  nn)\tSPECIAL PROCEDURE PACK, Model Number DYNJ38314G;  oo)\tMINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G;  pp)\tCARDIAC CATH PACK, Model Number DYNJ38866F;  qq)\tINTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B;  rr)\tABLATION PACK, Model Number DYNJ40629C;  ss)\tCATH LAB PACK, Model Number DYNJ40926A;  tt)\tRADIOLOGY PACK, Model Number DYNJ41190;  uu)\tTV IR PACK-LF, Model Number DYNJ41562F;  vv)\tCUSTOM ANGIO TRAY, Model Number DYNJ41649G;  ww)\tCARDIAC CATH DRAPE PACK, Model Number DYNJ41700A;  xx)\tIR PACK, Model Number DYNJ41989G;  yy)\tINTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C;  zz)\tANGIO PACK, Model Number DYNJ42903C;  aaa)\tANGIO PACK, Model Number DYNJ42903D;  bbb)\tCARDIAC CATH PACK-LF, Model Number DYNJ42996C;  ccc)\tDIALYSIS TRAY, Model Number DYNJ43060B;  ddd)\tANGIOPLASTY PACK-LF, Model Number DYNJ43203G;  eee)\tARTERIOGRAM PACK, Model Number DYNJ43261J;  fff)\tCATH LAB RIGHT HEART PACK, Model Number DYNJ43315L;  ggg)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609P;  hhh)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609R;  iii)\tANGIO CATH COMBINED PACK, Model Number DYNJ43609S;  jjj)\tANGIO PACK, Model Number DYNJ43661C;  kkk)\tABLATION EP PACK, Model Number DYNJ43851B;  lll)\tPK, RADIOLOGY, Model Number DYNJ43894B;  mmm)\tPK, RADIOLOGY, Model Number DYNJ44087A;  nnn)\tANGIOGRAPHY PACK, Model Number DYNJ44293F;  ooo)\tANGIO DRAPE PACK, Model Number DYNJ44320G;  ppp)\tANGIO DRAPE PACK, Model Number DYNJ44320I;  qqq)\tANGIO DRAPE PACK, Model Number DYNJ44320J;  rrr)\tFEMORAL ANGIO PACK, Model Number DYNJ44334M;  sss)\tFEMORAL ANGIO PACK, Model Number DYNJ44334N;  ttt)\tRADIOLOGY PACK, Model Number DYNJ44524F;  uuu)\tANGIO PACK, Model Number DYNJ44642B;  vvv)\tANGIOPLASTY PACK, Model Number DYNJ44700J;  www)\tANGIO PACK, Model Number DYNJ44993J;  xxx)\tANGIOGRAPHY PACK, Model Number DYNJ45059B;  yyy)\tPERCUTANEOUS PACK, Model Number D — 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 00-400305R, UDI/DI (EA) 10193489944280, UDI/DI (CS) 40193489944281;  b) Model Number DYNJ0037936C, UDI/DI (EA) 10195327031282, UDI/DI (CS) 40195327031283;  c) Model Number DYNJ0037936D, UDI/DI (EA) 10195327129538, UDI/DI (CS) 40195327129539;  d) Model Number DYNJ0149444N, UDI/DI (EA) 10193489966718, UDI/DI (CS) 40193489966719;  e) Model Number DYNJ0198765G, UDI/DI (EA) 10889942053988, UDI/DI (CS) 40889942053989;  f) Model Number DYNJ0275614F, UDI/DI (EA) 10889942174348, UDI/DI (CS) 40889942174349;  g) Model Number DYNJ0290716M, UDI/DI (EA) 10195327088866, UDI/DI (CS) 40195327088867;  h) Model Number DYNJ0313233V, UDI/DI (EA) 10889942247356, UDI/DI (CS) 40889942247357;  i) Model Number DYNJ0313233W, UDI/DI (EA) 10195327110970, UDI/DI (CS) 40195327110971;  j) Model Number DYNJ0313233X, UDI/DI (EA) 10195327250980, UDI/DI (CS) 40195327250981;  k) Model Number DYNJ0407399P, UDI/DI (EA) 10195327336868, UDI/DI (CS) 40195327336869;  l) Model Number DYNJ0416535AA, UDI/DI (EA) 10195327354596, UDI/DI (CS) 40195327354597;  m) Model Number DYNJ0429121K, UDI/DI (EA) 10195327069506, UDI/DI (CS) 40195327069507;  n) Model Number DYNJ0429185L, UDI/DI (EA) 10195327048976, UDI/DI (CS) 40195327048977;  o) Model Number DYNJ0458661C, UDI/DI (EA) 10889942550944, UDI/DI (CS) 40889942550945;  p) Model Number DYNJ0537652AG, UDI/DI (EA) 10195327017675, UDI/DI (CS) 40195327017676;  q) Model Number DYNJ0545064AA, UDI/DI (EA) 10195327327385, UDI/DI (CS) 40195327327386;  r) Model Number DYNJ0604508R, UDI/DI (EA) 10193489828443, UDI/DI (CS) 40193489828444;  s) Model Number DYNJ0842644F, UDI/DI (EA) 10195327288600, UDI/DI (CS) 40195327288601;  t) Model Number DYNJ0843244K, UDI/DI (EA) 10195327288594, UDI/DI (CS) 40195327288595;  u) Model Number DYNJ0854485V, UDI/DI (EA) 10195327096885, UDI/DI (CS) 40195327096886;  v) Model Number DYNJ0855138P, UDI/DI (EA) 10193489885132, UDI/DI (CS) 40193489885133;  w) Model Number DYNJ0855138Q, UDI/DI (EA) 10195327094843, UDI/DI (CS) 40195327094844;  x) Model Number DYNJ0950839C, UDI/DI (EA) 10889942101290, UDI/DI (CS) 40889942101291;  y) Model Number DYNJ23288C, UDI/DI (EA) 10193489954142, UDI/DI (CS) 40193489954143;  z) Model Number DYNJ23438M, UDI/DI (EA) 10193489970609, UDI/DI (CS) 40193489970600;  aa) Model Number DYNJ23455K, UDI/DI (EA) 10193489446296, UDI/DI (CS) 40193489446297;  bb) Model Number DYNJ23455L, UDI/DI (EA) 10193489977387, UDI/DI (CS) 40193489977388;  cc) Model Number DYNJ23455M, UDI/DI (EA) 10195327129835, UDI/DI (CS) 40195327129836;  dd) Model Number DYNJ23455N, UDI/DI (EA) 10195327237752, UDI/DI (CS) 40195327237753;  ee) Model Number DYNJ27613K, UDI/DI (EA) 10195327131180, UDI/DI (CS) 40195327131181;  ff) Model Number DYNJ33709F, UDI/DI (EA) 10889942713929, UDI/DI (CS) 40889942713920;  gg) Model Number DYNJ35164C, UDI/DI (EA) 10889942494668, UDI/DI (CS) 40889942494669;  hh) Model Number DYNJ35993F, UDI/DI (EA) 10195327398286, UDI/DI (CS) 40195327398287;  ii) Model Number DYNJ35994C, UDI/DI (EA) 10195327397951, UDI/DI (CS) 40195327397952;  jj) Model Number DYNJ36049A, UDI/DI (EA) 10195327147204, UDI/DI (CS) 40195327147205;  kk) Model Number DYNJ36738G, UDI/DI (EA) 10195327054168, UDI/DI (CS) 40195327054169;  ll) Model Number DYNJ36752B, UDI/DI (EA) 10195327226022, UDI/DI (CS) 40195327226023;  mm) Model Number DYNJ36807C, UDI/DI (EA) 10195327082222, UDI/DI (CS) 40195327082223;  nn) Model Number DYNJ38314G, UDI/DI (EA) 10193489603347, UDI/DI (CS) 40193489603348;  oo) Model Number DYNJ38326G, UDI/DI (EA) 10195327230135, UDI/DI (CS) 40195327230136;  pp) Model Number DYNJ38866F, UDI/DI (EA) 10193489914863, UDI/DI (CS) 40193489914864;  qq) Model Number DYNJ40215B, UDI/DI (EA) 10888277912267, UDI/DI (CS) 40888277912268;  rr) Model Number DYNJ40629C, UDI/DI (EA) 10193489997316, UDI/DI (CS) 40193489997317;  ss) Model Number DYNJ40926A, UDI/DI (EA) 10195327137212, UDI/DI (CS) 40195327137213;  tt) Model Number DYNJ41190, UDI/DI (EA) 10884389899083, UDI/DI (CS) 40884389899084;  uu) Model Number DYNJ41562F, UDI/DI (EA) 10193489641080, UDI/DI (CS) 40193489641081;  vv) Model Number DYNJ41649G, UDI/DI (EA) 10195327277291, UDI/DI (CS) 40195327277292;  ww) Model Number DYNJ41700A, UDI/DI (EA) 10889942756957, UDI/DI (CS) 40889942756958;  xx) Model Number DYNJ41989G, UDI/DI (EA) 10193489310801, UDI/DI (CS) 40193489310802;  yy) Model Number DYNJ42231C, UDI/DI (EA) 10195327026561, UDI/DI (CS) 40195327026562;  zz) Model Number DYNJ42903C, UDI/DI (EA) 10195327079666, UDI/DI (CS) 40195327079667;  aaa) Model Number DYNJ42903D, UDI/DI (EA) 10195327171117, UDI/DI (CS) 40195327171118;  bbb) Model Number DYNJ42996C, UDI/DI (EA) 10193489988437, UDI/DI (CS) 40193489988438;  ccc) Model Number DYNJ43060B, UDI/DI (EA) 10889942765850, UDI/DI (CS) 40889942765851;  ddd) Model Number DYNJ43203G, UDI/DI (EA) 10193489952919, UDI/DI (CS) 40193489952910;  eee) Model Number DYNJ43261J, UDI/DI (EA) 10195327288792, UDI/DI (CS) 40195327288793;  fff) Model Number DYNJ43315L, UDI/DI (EA) 10193489463675, UDI/DI (CS) 40193489463676;  ggg) Model Number DYNJ43609P, UDI/DI (EA) 10193489914535, UDI/DI (CS) 40193489914536;  hhh) Model Number DYNJ43609R, UDI/DI (EA) 10195327228781, UDI/DI (CS) 40195327228782;  iii) Model Number DYNJ43609S, UDI/DI (EA) 10195327322984, UDI/DI (CS) 40195327322985;  jjj) Model Number DYNJ43661C, UDI/DI (EA) 10195327104351, UDI/DI (CS) 40195327104352;  kkk) Model Number DYNJ43851B, UDI/DI (EA) 10195327200329, UDI/DI (CS) 40195327200320;  lll) Model Number DYNJ43894B, UDI/DI (EA) 10193489810486, UDI/DI (CS) 40193489810487;  mmm) Model Number DYNJ44087A, UDI/DI (EA) 10889942561803, UDI/DI (CS) 40889942561804;  nnn) Model Number DYNJ44293F, UDI/DI (EA) 10195327265182, UDI/DI (CS) 40195327265183;  ooo) Model Number DYNJ44320G, UDI/DI (EA) 10193489966305, UDI/DI (CS) 40193489966306;  ppp) Model Number DYNJ44320I, UDI/DI (EA) 10195327070359, UDI/DI (CS) 40195327070350;  qqq) Model Number DYNJ44320J, UDI/DI (EA) 10195327132354, UDI/DI (CS) 40195327132355;  rrr) Model Number DYNJ44334M, UDI/DI (EA) 10195327133115, UDI/DI (CS) 40195327133116;  sss) Model Number DYNJ44334N, UDI/DI (EA) 10195327299491, UDI/DI (CS) 40195327299492;  ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483;  uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421;  vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414;  www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923;  xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630;  yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642;  zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247;  aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424;  bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835;  cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473;  dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514;  eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024;  ffff) Model Number DYNJ47646I, UDI/DI (EA) 10195327357122, UDI/DI (CS) 40195327357123;  gggg) Model Number DYNJ47665D, UDI/DI (EA) 10193489952827, UDI/DI (CS) 40193489952828;  hhhh) Model Number DYNJ47665F, UDI/DI (EA) 10195327355210, UDI/DI (CS) 40195327355211;  iiii) Model Number DYNJ49621C, UDI/DI (EA) 10195327008581, UDI/DI (CS) 40195327008582;  jjjj) Model Number DYNJ50694A, UDI/DI (EA) 10889942693511, UDI/DI (CS) 40889942693512;  kkkk) Model Number DYNJ50712D, UDI/DI (EA) 10195327267926, UDI/DI (CS) 40195327267927;  llll) Model Number DYNJ51109B, UDI/DI (EA) 10889942456314, UDI/DI (CS) 40889942456315;  mmmm) Model Number DYNJ51240A, UDI/DI (EA) 10889942493524, UDI/DI (CS) 40889942493525;  nnnn) Model Number DYNJ51338C, UDI/DI (EA) 10193489241716, UDI/DI (CS) 40193489241717;  oooo) Model Number DYNJ52000B, UDI/DI (EA) 10193489384987, UDI/DI (CS) 40193489384988;  pppp) Model Number DYNJ52121A, UDI/DI (EA) 10195327260095, UDI/DI (CS) 40195327260096;  qqqq) Model Number DYNJ52425J, UDI/DI (EA) 10193489940145, UDI/DI (CS) 40193489940146;  rrrr) Model Number DYNJ52425K, UDI/DI (EA) 10195327042356, UDI/DI (CS) 40195327042357;  ssss) Model Number DYNJ52425L, UDI/DI (EA) 10195327074487, UDI/DI (CS) 40195327074488;  tttt) Model Number DYNJ52425M, UDI/DI (EA) 10195327177188, UDI/DI (CS) 40195327177189;  uuuu) Model Number DYNJ52425N, UDI/DI (EA) 10195327339326, UDI/DI (CS) 40195327339327;  vvvv) Model Number DYNJ52774, UDI/DI (EA) 10889942322473, UDI/DI (CS) 40889942322474;  wwww) Model Number DYNJ52806C, UDI/DI (EA) 10193489292909, UDI/DI (CS) 40193489292900;  xxxx) Model Number DYNJ53095, UDI/DI (EA) 10889942371778, UDI/DI (CS) 40889942371779;  yyyy) Model Number DYNJ53481D, UDI/DI (EA) 10193489812572, UDI/DI (CS) 40193489812573;  zzzz) Model Number DYNJ54755I, UDI/DI (EA) 10195327021269, UDI/DI (CS) 40195327021260. 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-2160-2023&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-2160-2023&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-2160-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2160-2023 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-2160-2023&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-2160-2023&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-2160-2023/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-2160-2023",
      "numberOfItems": 9,
      "itemListElement": [
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2160-2023",
            "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": {
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 ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483;  uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421;  vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414;  www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923;  xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630;  yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642;  zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247;  aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424;  bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835;  cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473;  dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514;  eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024; 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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"
          }
        }
      ]
    }
  ]
}