{
  "@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-2168-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number",
  "description": "FDA recall Z-2168-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number (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-2168-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2168-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2168-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number",
      "text": "The FDA logged enforcement record Z-2168-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tPORT PACK, Model Number DYNJ64675;  b)\tPICC LINE TRAY, Model Number DYNJ64725B;  c)\tVEIN OHH, Model Number DYNJ65560C;  d)\tPORT PICC TUNNEL PACK, Model Number DYNJ65775;  e)\tENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827;  f)\tPICC PACK, Model Number DYNJ65838;  g)\tJVL-PACK PICC, Model Number DYNJ66062;  h)\tFISTULAGRAM PACK, Model Number DYNJ66259;  i)\tVEIN PACK-LF, Model Number DYNJ66271B;  j)\tVEIN PACK-LF, Model Number DYNJ66271D;  k)\tVASCULAR PACK, Model Number DYNJ66356F;  l)\tVENOUS PACK, Model Number DYNJ66499A;  m)\tVENOUS PACK, Model Number DYNJ66499B;  n)\tVEIN PACK, Model Number DYNJ66743B;  o)\tAV FISTULA PACK, Model Number DYNJ66916;  p)\tVEIN ABLATION PLUS W CHL, Model Number DYNJ67115A;  q)\tPICC INSERTION TRAY, Model Number DYNJ67415;  r)\tAFCH CVC INSERTION, Model Number DYNJ67534;  s)\tENS PICC LINE-HEJ-LF, Model Number DYNJ67606;  t)\tVEIN TRAY, Model Number DYNJ69012A;  u)\tPICC PACK, Model Number DYNJ69088;  v)\tPICC PACK, Model Number DYNJ69088A;  w)\tVEIN PACK, Model Number DYNJ69091A;  x)\tVEIN PACK, Model Number DYNJ69091B;  y)\tVEIN PACK, Model Number DYNJ69177;  z)\tVEIN ABLATION KIT, Model Number DYNJ69272;  aa)\tVEIN ABLATION PACK, Model Number DYNJ69288;  bb)\tBASIC VEIN PACK, Model Number DYNJ69426;  cc)\tVASCULAR VEIN PACK, Model Number DYNJ69769;  dd)\tBCH VEIN ABLATION, Model Number DYNJ69796;  ee)\tVEIN PACK, Model Number DYNJ69942A;  ff)\tFISTULA SAVANNAH PACK, Model Number DYNJ69943;  gg)\tVEIN CLOSURE PACK, Model Number DYNJ69976;  hh)\tVEIN CLOSURE PACK, Model Number DYNJ69976A;  ii)\tVENCLOSE PROCEDURE PACK, Model Number DYNJ80123;  jj)\tVENOUS PACK, Model Number DYNJ80169;  kk)\tVENOUS PACK, Model Number DYNJ80169A;  ll)\tCVR ENDOVENOUS PACK, Model Number DYNJ80643;  mm)\tVENOUS PACK, Model Number DYNJ80692;  nn)\tVENOUS PACK, Model Number DYNJ80692A;  oo)\tVEIN PACK, Model Number DYNJ81120;  pp)\tVEIN PROCEDURE PACK, Model Number DYNJ81177;  qq)\tVEIN PACK, Model Number DYNJ81212A;  rr)\tSUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267;  ss)\tOR VASCULAR ANGIO PACK, Model Number DYNJ81592;  tt)\tPARAGON VEIN PACK, Model Number DYNJ81669;  uu)\tPARAGON VEIN PACK, Model Number DYNJ81669B;  vv)\tANGIOGRAM-DECH-LF, Model Number DYNJ81725;  ww)\tPICC-DECH-LF, Model Number DYNJ81726;  xx)\tVEIN CLOSURE PACK, Model Number DYNJ81834;  yy)\tVEIN PACK, Model Number DYNJ82033;  zz)\tVEIN PACK, Model Number DYNJ82033A;  aaa)\tSUPERFICIAL VENOUS PACK, Model Number DYNJ82100;  bbb)\tSUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101;  ccc)\tVEIN PROCEDURE TRAY, Model Number DYNJ82581;  ddd)\tVARICOSE VEIN PACK, Model Number DYNJ82884;  eee)\tVARICOSE VEIN PACK, Model Number DYNJ82885;  fff)\tLASER VEIN EC PACK, Model Number DYNJ82951;  ggg)\tSUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989;  hhh)\tPORT DIALYSIS PACK, Model Number DYNJ83087;  iii)\tDEXMED ACCESS PACK, Model Number DYNJ83148;  jjj)\tVEIN TRAY, Model Number DYNJ83384A;  kkk)\tRADIO VEIN ABLATION PACK, Model Number DYNJ83534;  lll)\tVEIN PACK, Model Number DYNJ83747;  mmm)\tVEIN ABLATION PACK, Model Number DYNJ83846;  nnn)\tVEIN PACK, Model Number DYNJ83914;  ooo)\tVEIN PACK, Model Number DYNJ83935;  ppp)\tVEIN ABLATION PACK, Model Number DYNJ83974;  qqq)\tVENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I;  rrr)\tVASCULAR ACCESS-LF, Model Number DYNJ905285D;  sss)\tGENERAL AV FISTULA, Model Number DYNJ906011B;  ttt)\tKIT VEIN ABLATION, Model Number DYNJ907381;  uuu)\tOPEN VASCULAR UE, Model Number DYNJ907858;  vvv)\tPICC LINE TRAY-LF, Model Number DYNJT2272J;  www)\tPICC LINE TRAY-LF, Model Number DYNJT2272K;  xxx)\tPICC CUSTOM PACK, Model Number GSS584Q;  yyy)\tULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A;  zzz)\tPEDS/ NICU LINE KIT, Model Number MNS13555;  aaaa)\tER CENTRAL LINE KIT, Model Number P155508D;  bbbb)\tPICC INSERTION TRAY, Model Number PICC0018;  cccc)\tPICC TRAY, Model Number PICCNC0008;  dddd)\tPQ PICC LINE PACK, Model Number PICCNC0013;  eeee)\tSTANDARD PICC II-LF, Model Number — 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 DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144;  b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847;  c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810;  d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825;  e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490;  f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262;  g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218;  h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486;  i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918;  j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740;  k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013;  l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524;  m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108;  n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798;  o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651;  p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881;  q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888;  r) Model Number DYNJ67534, UDI/DI (EA) 10193489409321,UDI/DI (CS) 40193489409322;  s) Model Number DYNJ67606, UDI/DI (EA) 10193489421675,UDI/DI (CS) 40193489421676;  t) Model Number DYNJ69012A, UDI/DI (EA) 10195327331719,UDI/DI (CS) 40195327331710;  u) Model Number DYNJ69088, UDI/DI (EA) 10193489883619,UDI/DI (CS) 40193489883610;  v) Model Number DYNJ69088A, UDI/DI (EA) 10193489975246,UDI/DI (CS) 40193489975247;  w) Model Number DYNJ69091A, UDI/DI (EA) 10193489969764,UDI/DI (CS) 40193489969765;  x) Model Number DYNJ69091B, UDI/DI (EA) 10195327178994,UDI/DI (CS) 40195327178995;  y) Model Number DYNJ69177, UDI/DI (EA) 10193489902198,UDI/DI (CS) 40193489902199;  z) Model Number DYNJ69272, UDI/DI (EA) 10193489920338,UDI/DI (CS) 40193489920339;  aa) Model Number DYNJ69288, UDI/DI (EA) 10193489922677,UDI/DI (CS) 40193489922678;  bb) Model Number DYNJ69426, UDI/DI (EA) 10193489939392,UDI/DI (CS) 40193489939393;  cc) Model Number DYNJ69769, UDI/DI (EA) 10193489977790,UDI/DI (CS) 40193489977791;  dd) Model Number DYNJ69796, UDI/DI (EA) 10193489979350,UDI/DI (CS) 40193489979351;  ee) Model Number DYNJ69942A, UDI/DI (EA) 10195327284626,UDI/DI (CS) 40195327284627;  ff) Model Number DYNJ69943, UDI/DI (EA) 10193489998443,UDI/DI (CS) 40193489998444;  gg) Model Number DYNJ69976, UDI/DI (EA) 10195327001308,UDI/DI (CS) 40195327001309;  hh) Model Number DYNJ69976A, UDI/DI (EA) 10195327130398,UDI/DI (CS) 40195327130399;  ii) Model Number DYNJ80123, UDI/DI (EA) 10195327009182,UDI/DI (CS) 40195327009183;  jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449;  kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740;  ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791;  mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547;  nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828;  oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880;  pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611;  qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864;  rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443;  ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773;  tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324;  uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432;  vv) Model Number DYNJ81725, UDI/DI (EA) 10195327136758,UDI/DI (CS) 40195327136759;  ww) Model Number DYNJ81726, UDI/DI (EA) 10195327136772,UDI/DI (CS) 40195327136773;  xx) Model Number DYNJ81834, UDI/DI (EA) 10195327147853,UDI/DI (CS) 40195327147854;  yy) Model Number DYNJ82033, UDI/DI (EA) 10195327162979,UDI/DI (CS) 40195327162970;  zz) Model Number DYNJ82033A, UDI/DI (EA) 10195327271442,UDI/DI (CS) 40195327271443;  aaa) Model Number DYNJ82100, UDI/DI (EA) 10195327170592,UDI/DI (CS) 40195327170593;  bbb) Model Number DYNJ82101, UDI/DI (EA) 10195327170585,UDI/DI (CS) 40195327170586;  ccc) Model Number DYNJ82581, UDI/DI (EA) 10195327198657,UDI/DI (CS) 40195327198658;  ddd) Model Number DYNJ82884, UDI/DI (EA) 10195327215996,UDI/DI (CS) 40195327215997;  eee) Model Number DYNJ82885, UDI/DI (EA) 10195327216009,UDI/DI (CS) 40195327216000;  fff) Model Number DYNJ82951, UDI/DI (EA) 10195327218973,UDI/DI (CS) 40195327218974;  ggg) Model Number DYNJ82989, UDI/DI (EA) 10195327221768,UDI/DI (CS) 40195327221769;  hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256;  iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513;  jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813;  kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714;  lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730;  mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491;  nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129;  ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544;  ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142;  qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568;  rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669;  sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233;  ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775;  uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358;  vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325;  www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677;  xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020;  yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917;  zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954;  aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062;  bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393;  cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585;  dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224;  eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190;  ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659;  gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106;  hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090;  iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680;. 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-2168-2023&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-2168-2023&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-2168-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2168-2023 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-2168-2023&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-2168-2023&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-2168-2023/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-2168-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2168-2023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144;  b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847;  c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810;  d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825;  e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490;  f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262;  g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218;  h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486;  i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918;  j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740;  k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013; 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 jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449;  kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740;  ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791;  mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547;  nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828;  oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880;  pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611;  qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864;  rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443;  ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773;  tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324;  uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432; 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 hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256;  iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513;  jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813;  kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714;  lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730;  mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491;  nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129;  ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544;  ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142;  qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568;  rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669;  sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233;  ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775;  uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358;  vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325;  www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677;  xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020;  yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917;  zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954;  aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062;  bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393;  cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585;  dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224;  eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190;  ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659;  gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106;  hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090;  iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680;",
            "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"
          }
        }
      ]
    }
  ]
}