{
  "@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-1111-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits, trays, and packs labeled as follows:    a)\t709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;   b)\tABDOMEN PACK, REF DYNJ53643C;   c)\tBAG TRUNK STOCK KIT, REF DYKM1880;   d)\tBEDSIDE BRONCH PACK, REF DYKE1601;   e)\tBIOPSY TRAY, REF DYNDH1242;   f)\tBRONCH KIT, REF DYKE1840;   g)\tBRONCHOSCOPY PACK, REF DYNJ37775F;   h)\tBRONCHOSCOPY TRAY, REF DYNDL1350A;   i)\tBRONCHOSCOPY TRAY, REF DYNDL1350AH;   j)\tCAP CHANGE LARGE KIT, REF DYNDA2277A;   k)\tCAP CHANGE LARGE KIT, REF DYNDA2277B;   l)\tDAILY VAD DRIVELINE KIT, REF DYNDC3006;   m)\tDAILY VENT KIT, REF DYNDJ1076;   n)\tDIALYSIS OFF KIT, REF DT21230A;   o)\tDIALYSIS OFF KIT, REF DT20350B;   p)\tDIALYSIS ON KIT, REF DT20355B;   q)\tDOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;   r)\tDR D CUSTOM PACK, REF DYNJ68068A;   s)\tDR D CUSTOM PACK, REF DYNJ68068B;   t)\tDUODENUM CULTURING PACK, REF DYNJ51294;   u)\tEGD SOUTHEASTERN REG KIT, REF DYKE1830;   v)\tEMERGENCY UMBILICAL INSERTION, REF UVT1165;   w)\tENDO KIT, REF DYKE1069B;   x)\tENDO KIT, REF DYKE1475B;   y)\tERCP ENDO KIT, REF P604360B;   z)\tERCP SOUTHEASTERN REG KIT, REF DYKM2127;   aa)\tFACIAL PLASTY PACK, REF DYNJ55335D;   bb)\tFIRST YEAR KIT LF, REF EDUC1037;   cc)\tFOLEY BULB INDUCTION KIT, REF MNS13545;   dd)\tG BUNDLE CDS, REF CDS982759;   ee)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;   ff)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;   gg)\tGENERAL/HERNIA PACK, REF DYNJ38541B;   hh)\tGI BRONCHOSCOPY KIT, REF DYKE1254C;   ii)\tHH CAR STOCK IN BIN, REF DYKM1883;   jj)\tIMMERSION 4, REF EDUC05059A;   kk)\tKIT LINE INSERTION, REF CVI4730;   ll)\tKIT, PEG, SOUTHEASTERN REG, REF DYKM2128;   mm)\tLINE INSERT PACK, REF PHS422216004C;   nn)\tMANUAL BLADDER IRRIGATION KIT, REF UROT1051;   oo)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;   pp)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;   qq)\tMOHS KIT, REF DYNDA2072A;   rr)\tMULTI LUMEN CAP CHANGE, REF DYNDA2390A;   ss)\tN HOME CARE WOUND KIT, REF DYK1188079W;   tt)\tNURSE KIT NO LOGO-LF, REF EDUC05036;   uu)\tNURSE TOTE, REF DYKM1872A;   vv)\tNURSING SKILLS, REF EDUC05015A;   ww)\tPICC, REF CDS980470D;   xx)\tPRE OP KIT, REF DYKS1262A;   yy)\tPULMONARY SETUP KIT, REF DYNDA2648;   zz)\tPULMONARY SETUP KIT, REF DYNDA2648H;   aaa)\tREDDY JOINT BATH, REF MMJB001;   bbb)\tREDDY JOINT BATH, REF MMJB001A;   ccc)\tRNSG 1441, REF EDUC1029;   ddd)\tRNSG 1441, REF EDUC1029H;   eee)\tRNSG 2201, REF EDUC1034;   fff)\tRNSG 2201, REF EDUC1034H;   ggg)\tSENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;   hhh)\tSHEATH REMOVAL TRAY, REF DYNDC1311C;   iii)\tSHORT TERM KIT, REF DYNDC3092;   jjj)\tSINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;   kkk)\tSTERILE CAP CHANGE, REF DYNDA2387A;   lll)\tSTERILE PREP KIT, REF DYNDA1359;   mmm)\tSTERILE PREP KIT, REF DYNDA1359A;   nnn)\tSTRL EK SINGLE PACK, REF DYNDA1360B;   ooo)\tSUB PORT ACCESS TRAY, REF DYNDC2768A;   ppp)\tSUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;   qqq)\tSURGICAL PREP KIT, REF DYNJ46340B;   rrr)\tSUTURE KIT, REF M101494;   sss)\tSUTURE TRAY, REF DYNDS1085A;   ttt)\tTRUNK KIT, REF DYKTRUNK1;   uuu)\tTRUNK KIT 1EA, REF DYKM2013;   vvv)\tUMBILICAL VESSEL INSERTION, REF DYNDA3011;   www)\tURINALYSIS KIT, REF DYKM1251;   xxx)\tVAD ACCESS CHANGE KIT, REF DYNDC2882B;   yyy)\tVAD DRESSING KIT A, REF DYNDA2164;   zzz)      CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;   aaaa)   CVC DRESSING CHANGE KIT, REF EBSI1552;   bbbb)   PORT ACCESS POWER LOC KIT, REF DYNDC1712B;   cccc)     PORT ACCESS TRAY, REF DYNDC1128B;",
  "description": "FDA recall Z-1111-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a)\t709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;   b)\tABDOMEN PACK, REF DYNJ53643C;   c)\tBAG TRUNK STOCK KIT, REF DYKM1880;   d)\tBEDSIDE BRONCH PACK, REF DYKE1601;   e)\tBIOPSY TRAY, REF DYNDH1242;   f)\tBRONCH KIT, REF DYKE1840;   g)\tBRONCHOSCOPY PACK, REF DYNJ37775F;   h)\tBRONCHOSCOPY TRAY, REF DYNDL1350A;   i)\tBRONCHOSCOPY TRAY, REF DYNDL1350AH;   j)\tCAP CHANGE LARGE KIT, REF DYNDA2277A;   k)\tCAP CHANGE LARGE KIT, REF DYNDA2277B;   l)\tDAILY VAD DRIVELINE KIT, REF DYNDC3006;   m)\tDAILY VENT KIT, REF DYNDJ1076;   n)\tDIALYSIS OFF KIT, REF DT21230A;   o)\tDIALYSIS OFF KIT, REF DT20350B;   p)\tDIALYSIS ON KIT, REF DT20355B;   q)\tDOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;   r)\tDR D CUSTOM PACK, REF DYNJ68068A;   s)\tDR D CUSTOM PACK, REF DYNJ68068B;   t)\tDUODENUM CULTURING PACK, REF DYNJ51294;   u)\tEGD SOUTHEASTERN REG KIT, REF DYKE1830;   v)\tEMERGENCY UMBILICAL INSERTION, REF UVT1165;   w)\tENDO KIT, REF DYKE1069B;   x)\tENDO KIT, REF DYKE1475B;   y)\tERCP ENDO KIT, REF P604360B;   z)\tERCP SOUTHEASTERN REG KIT, REF DYKM2127;   aa)\tFACIAL PLASTY PACK, REF DYNJ55335D;   bb)\tFIRST YEAR KIT LF, REF EDUC1037;   cc)\tFOLEY BULB INDUCTION KIT, REF MNS13545;   dd)\tG BUNDLE CDS, REF CDS982759;   ee)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;   ff)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;   gg)\tGENERAL/HERNIA PACK, REF DYNJ38541B;   hh)\tGI BRONCHOSCOPY KIT, REF DYKE1254C;   ii)\tHH CAR STOCK IN BIN, REF DYKM1883;   jj)\tIMMERSION 4, REF EDUC05059A;   kk)\tKIT LINE INSERTION, REF CVI4730;   ll)\tKIT, PEG, SOUTHEASTERN REG, REF DYKM2128;   mm)\tLINE INSERT PACK, REF PHS422216004C;   nn)\tMANUAL BLADDER IRRIGATION KIT, REF UROT1051;   oo)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;   pp)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;   qq)\tMOHS KIT, REF DYNDA2072A;   rr)\tMULTI LUMEN CAP CHANGE, REF DYNDA2390A;   ss)\tN HOME CARE WOUND KIT, REF DYK1188079W;   tt)\tNURSE KIT NO LOGO-LF, REF EDUC05036;   uu)\tNURSE TOTE, REF DYKM1872A;   vv)\tNURSING SKILLS, REF EDUC05015A;   ww)\tPICC, REF CDS980470D;   xx)\tPRE OP KIT, REF DYKS1262A;   yy)\tPULMONARY SETUP KIT, REF DYNDA2648;   zz)\tPULMONARY SETUP KIT, REF DYNDA2648H;   aaa)\tREDDY JOINT BATH, REF MMJB001;   bbb)\tREDDY JOINT BATH, REF MMJB001A;   ccc)\tRNSG 1441, REF EDUC1029;   ddd)\tRNSG 1441, REF EDUC1029H;   eee)\tRNSG 2201, REF EDUC1034;   fff)\tRNSG 2201, REF EDUC1034H;   ggg)\tSENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;   hhh)\tSHEATH REMOVAL TRAY, REF DYNDC1311C;   iii)\tSHORT TERM KIT, REF DYNDC3092;   jjj)\tSINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;   kkk)\tSTERILE CAP CHANGE, REF DYNDA2387A;   lll)\tSTERILE PREP KIT, REF DYNDA1359;   mmm)\tSTERILE PREP KIT, REF DYNDA1359A;   nnn)\tSTRL EK SINGLE PACK, REF DYNDA1360B;   ooo)\tSUB PORT ACCESS TRAY, REF DYNDC2768A;   ppp)\tSUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;   qqq)\tSURGICAL PREP KIT, REF DYNJ46340B;   rrr)\tSUTURE KIT, REF M101494;   sss)\tSUTURE TRAY, REF DYNDS1085A;   ttt)\tTRUNK KIT, REF DYKTRUNK1;   uuu)\tTRUNK KIT 1EA, REF DYKM2013;   vvv)\tUMBILICAL VESSEL INSERTION, REF DYNDA3011;   www)\tURINALYSIS KIT, REF DYKM1251;   xxx)\tVAD ACCESS CHANGE KIT, REF DYNDC2882B;   yyy)\tVAD DRESSING KIT A, REF DYNDA2164;   zzz)      CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;   aaaa)   CVC DRESSING CHANGE KIT, REF EBSI1552;   bbbb)   PORT ACCESS POWER LOC KIT, REF DYNDC1712B;   cccc)     PORT ACCESS TRAY, REF DYNDC1128B; (Devices, Class I). 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-1111-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits, trays, and packs labeled as follows:    a)\t709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;   b)\tABDOMEN PACK, REF DYNJ53643C;   c)\tBAG TRUNK STOCK KIT, REF DYKM1880;   d)\tBEDSIDE BRONCH PACK, REF DYKE1601;   e)\tBIOPSY TRAY, REF DYNDH1242;   f)\tBRONCH KIT, REF DYKE1840;   g)\tBRONCHOSCOPY PACK, REF DYNJ37775F;   h)\tBRONCHOSCOPY TRAY, REF DYNDL1350A;   i)\tBRONCHOSCOPY TRAY, REF DYNDL1350AH;   j)\tCAP CHANGE LARGE KIT, REF DYNDA2277A;   k)\tCAP CHANGE LARGE KIT, REF DYNDA2277B;   l)\tDAILY VAD DRIVELINE KIT, REF DYNDC3006;   m)\tDAILY VENT KIT, REF DYNDJ1076;   n)\tDIALYSIS OFF KIT, REF DT21230A;   o)\tDIALYSIS OFF KIT, REF DT20350B;   p)\tDIALYSIS ON KIT, REF DT20355B;   q)\tDOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;   r)\tDR D CUSTOM PACK, REF DYNJ68068A;   s)\tDR D CUSTOM PACK, REF DYNJ68068B;   t)\tDUODENUM CULTURING PACK, REF DYNJ51294;   u)\tEGD SOUTHEASTERN REG KIT, REF DYKE1830;   v)\tEMERGENCY UMBILICAL INSERTION, REF UVT1165;   w)\tENDO KIT, REF DYKE1069B;   x)\tENDO KIT, REF DYKE1475B;   y)\tERCP ENDO KIT, REF P604360B;   z)\tERCP SOUTHEASTERN REG KIT, REF DYKM2127;   aa)\tFACIAL PLASTY PACK, REF DYNJ55335D;   bb)\tFIRST YEAR KIT LF, REF EDUC1037;   cc)\tFOLEY BULB INDUCTION KIT, REF MNS13545;   dd)\tG BUNDLE CDS, REF CDS982759;   ee)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;   ff)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;   gg)\tGENERAL/HERNIA PACK, REF DYNJ38541B;   hh)\tGI BRONCHOSCOPY KIT, REF DYKE1254C;   ii)\tHH CAR STOCK IN BIN, REF DYKM1883;   jj)\tIMMERSION 4, REF EDUC05059A;   kk)\tKIT LINE INSERTION, REF CVI4730;   ll)\tKIT, PEG, SOUTHEASTERN REG, REF DYKM2128;   mm)\tLINE INSERT PACK, REF PHS422216004C;   nn)\tMANUAL BLADDER IRRIGATION KIT, REF UROT1051;   oo)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;   pp)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;   qq)\tMOHS KIT, REF DYNDA2072A;   rr)\tMULTI LUMEN CAP CHANGE, REF DYNDA2390A;   ss)\tN HOME CARE WOUND KIT, REF DYK1188079W;   tt)\tNURSE KIT NO LOGO-LF, REF EDUC05036;   uu)\tNURSE TOTE, REF DYKM1872A;   vv)\tNURSING SKILLS, REF EDUC05015A;   ww)\tPICC, REF CDS980470D;   xx)\tPRE OP KIT, REF DYKS1262A;   yy)\tPULMONARY SETUP KIT, REF DYNDA2648;   zz)\tPULMONARY SETUP KIT, REF DYNDA2648H;   aaa)\tREDDY JOINT BATH, REF MMJB001;   bbb)\tREDDY JOINT BATH, REF MMJB001A;   ccc)\tRNSG 1441, REF EDUC1029;   ddd)\tRNSG 1441, REF EDUC1029H;   eee)\tRNSG 2201, REF EDUC1034;   fff)\tRNSG 2201, REF EDUC1034H;   ggg)\tSENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;   hhh)\tSHEATH REMOVAL TRAY, REF DYNDC1311C;   iii)\tSHORT TERM KIT, REF DYNDC3092;   jjj)\tSINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;   kkk)\tSTERILE CAP CHANGE, REF DYNDA2387A;   lll)\tSTERILE PREP KIT, REF DYNDA1359;   mmm)\tSTERILE PREP KIT, REF DYNDA1359A;   nnn)\tSTRL EK SINGLE PACK, REF DYNDA1360B;   ooo)\tSUB PORT ACCESS TRAY, REF DYNDC2768A;   ppp)\tSUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;   qqq)\tSURGICAL PREP KIT, REF DYNJ46340B;   rrr)\tSUTURE KIT, REF M101494;   sss)\tSUTURE TRAY, REF DYNDS1085A;   ttt)\tTRUNK KIT, REF DYKTRUNK1;   uuu)\tTRUNK KIT 1EA, REF DYKM2013;   vvv)\tUMBILICAL VESSEL INSERTION, REF DYNDA3011;   www)\tURINALYSIS KIT, REF DYKM1251;   xxx)\tVAD ACCESS CHANGE KIT, REF DYNDC2882B;   yyy)\tVAD DRESSING KIT A, REF DYNDA2164;   zzz)      CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;   aaaa)   CVC DRESSING CHANGE KIT, REF EBSI1552;   bbbb)   PORT ACCESS POWER LOC KIT, REF DYNDC1712B;   cccc)     PORT ACCESS TRAY, REF DYNDC1128B;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1111-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1111-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a)\t709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;   b)\tABDOMEN PACK, REF DYNJ53643C;   c)\tBAG TRUNK STOCK KIT, REF DYKM1880;   d)\tBEDSIDE BRONCH PACK, REF DYKE1601;   e)\tBIOPSY TRAY, REF DYNDH1242;   f)\tBRONCH KIT, REF DYKE1840;   g)\tBRONCHOSCOPY PACK, REF DYNJ37775F;   h)\tBRONCHOSCOPY TRAY, REF DYNDL1350A;   i)\tBRONCHOSCOPY TRAY, REF DYNDL1350AH;   j)\tCAP CHANGE LARGE KIT, REF DYNDA2277A;   k)\tCAP CHANGE LARGE KIT, REF DYNDA2277B;   l)\tDAILY VAD DRIVELINE KIT, REF DYNDC3006;   m)\tDAILY VENT KIT, REF DYNDJ1076;   n)\tDIALYSIS OFF KIT, REF DT21230A;   o)\tDIALYSIS OFF KIT, REF DT20350B;   p)\tDIALYSIS ON KIT, REF DT20355B;   q)\tDOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;   r)\tDR D CUSTOM PACK, REF DYNJ68068A;   s)\tDR D CUSTOM PACK, REF DYNJ68068B;   t)\tDUODENUM CULTURING PACK, REF DYNJ51294;   u)\tEGD SOUTHEASTERN REG KIT, REF DYKE1830;   v)\tEMERGENCY UMBILICAL INSERTION, REF UVT1165;   w)\tENDO KIT, REF DYKE1069B;   x)\tENDO KIT, REF DYKE1475B;   y)\tERCP ENDO KIT, REF P604360B;   z)\tERCP SOUTHEASTERN REG KIT, REF DYKM2127;   aa)\tFACIAL PLASTY PACK, REF DYNJ55335D;   bb)\tFIRST YEAR KIT LF, REF EDUC1037;   cc)\tFOLEY BULB INDUCTION KIT, REF MNS13545;   dd)\tG BUNDLE CDS, REF CDS982759;   ee)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;   ff)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;   gg)\tGENERAL/HERNIA PACK, REF DYNJ38541B;   hh)\tGI BRONCHOSCOPY KIT, REF DYKE1254C;   ii)\tHH CAR STOCK IN BIN, REF DYKM1883;   jj)\tIMMERSION 4, REF EDUC05059A;   kk)\tKIT LINE INSERTION, REF CVI4730;   ll)\tKIT, PEG, SOUTHEASTERN REG, REF DYKM2128;   mm)\tLINE INSERT PACK, REF PHS422216004C;   nn)\tMANUAL BLADDER IRRIGATION KIT, REF UROT1051;   oo)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;   pp)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;   qq)\tMOHS KIT, REF DYNDA2072A;   rr)\tMULTI LUMEN CAP CHANGE, REF DYNDA2390A;   ss)\tN HOME CARE WOUND KIT, REF DYK1188079W;   tt)\tNURSE KIT NO LOGO-LF, REF EDUC05036;   uu)\tNURSE TOTE, REF DYKM1872A;   vv)\tNURSING SKILLS, REF EDUC05015A;   ww)\tPICC, REF CDS980470D;   xx)\tPRE OP KIT, REF DYKS1262A;   yy)\tPULMONARY SETUP KIT, REF DYNDA2648;   zz)\tPULMONARY SETUP KIT, REF DYNDA2648H;   aaa)\tREDDY JOINT BATH, REF MMJB001;   bbb)\tREDDY JOINT BATH, REF MMJB001A;   ccc)\tRNSG 1441, REF EDUC1029;   ddd)\tRNSG 1441, REF EDUC1029H;   eee)\tRNSG 2201, REF EDUC1034;   fff)\tRNSG 2201, REF EDUC1034H;   ggg)\tSENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;   hhh)\tSHEATH REMOVAL TRAY, REF DYNDC1311C;   iii)\tSHORT TERM KIT, REF DYNDC3092;   jjj)\tSINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;   kkk)\tSTERILE CAP CHANGE, REF DYNDA2387A;   lll)\tSTERILE PREP KIT, REF DYNDA1359;   mmm)\tSTERILE PREP KIT, REF DYNDA1359A;   nnn)\tSTRL EK SINGLE PACK, REF DYNDA1360B;   ooo)\tSUB PORT ACCESS TRAY, REF DYNDC2768A;   ppp)\tSUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;   qqq)\tSURGICAL PREP KIT, REF DYNJ46340B;   rrr)\tSUTURE KIT, REF M101494;   sss)\tSUTURE TRAY, REF DYNDS1085A;   ttt)\tTRUNK KIT, REF DYKTRUNK1;   uuu)\tTRUNK KIT 1EA, REF DYKM2013;   vvv)\tUMBILICAL VESSEL INSERTION, REF DYNDA3011;   www)\tURINALYSIS KIT, REF DYKM1251;   xxx)\tVAD ACCESS CHANGE KIT, REF DYNDC2882B;   yyy)\tVAD DRESSING KIT A, REF DYNDA2164;   zzz)      CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;   aaaa)   CVC DRESSING CHANGE KIT, REF EBSI1552;   bbbb)   PORT ACCESS POWER LOC KIT, REF DYNDC1712B;   cccc)     PORT ACCESS TRAY, REF DYNDC1128B;",
      "text": "The FDA logged enforcement record Z-1111-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits, trays, and packs labeled as follows:    a)\t709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;   b)\tABDOMEN PACK, REF DYNJ53643C;   c)\tBAG TRUNK STOCK KIT, REF DYKM1880;   d)\tBEDSIDE BRONCH PACK, REF DYKE1601;   e)\tBIOPSY TRAY, REF DYNDH1242;   f)\tBRONCH KIT, REF DYKE1840;   g)\tBRONCHOSCOPY PACK, REF DYNJ37775F;   h)\tBRONCHOSCOPY TRAY, REF DYNDL1350A;   i)\tBRONCHOSCOPY TRAY, REF DYNDL1350AH;   j)\tCAP CHANGE LARGE KIT, REF DYNDA2277A;   k)\tCAP CHANGE LARGE KIT, REF DYNDA2277B;   l)\tDAILY VAD DRIVELINE KIT, REF DYNDC3006;   m)\tDAILY VENT KIT, REF DYNDJ1076;   n)\tDIALYSIS OFF KIT, REF DT21230A;   o)\tDIALYSIS OFF KIT, REF DT20350B;   p)\tDIALYSIS ON KIT, REF DT20355B;   q)\tDOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;   r)\tDR D CUSTOM PACK, REF DYNJ68068A;   s)\tDR D CUSTOM PACK, REF DYNJ68068B;   t)\tDUODENUM CULTURING PACK, REF DYNJ51294;   u)\tEGD SOUTHEASTERN REG KIT, REF DYKE1830;   v)\tEMERGENCY UMBILICAL INSERTION, REF UVT1165;   w)\tENDO KIT, REF DYKE1069B;   x)\tENDO KIT, REF DYKE1475B;   y)\tERCP ENDO KIT, REF P604360B;   z)\tERCP SOUTHEASTERN REG KIT, REF DYKM2127;   aa)\tFACIAL PLASTY PACK, REF DYNJ55335D;   bb)\tFIRST YEAR KIT LF, REF EDUC1037;   cc)\tFOLEY BULB INDUCTION KIT, REF MNS13545;   dd)\tG BUNDLE CDS, REF CDS982759;   ee)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;   ff)\tGBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;   gg)\tGENERAL/HERNIA PACK, REF DYNJ38541B;   hh)\tGI BRONCHOSCOPY KIT, REF DYKE1254C;   ii)\tHH CAR STOCK IN BIN, REF DYKM1883;   jj)\tIMMERSION 4, REF EDUC05059A;   kk)\tKIT LINE INSERTION, REF CVI4730;   ll)\tKIT, PEG, SOUTHEASTERN REG, REF DYKM2128;   mm)\tLINE INSERT PACK, REF PHS422216004C;   nn)\tMANUAL BLADDER IRRIGATION KIT, REF UROT1051;   oo)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;   pp)\tMANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;   qq)\tMOHS KIT, REF DYNDA2072A;   rr)\tMULTI LUMEN CAP CHANGE, REF DYNDA2390A;   ss)\tN HOME CARE WOUND KIT, REF DYK1188079W;   tt)\tNURSE KIT NO LOGO-LF, REF EDUC05036;   uu)\tNURSE TOTE, REF DYKM1872A;   vv)\tNURSING SKILLS, REF EDUC05015A;   ww)\tPICC, REF CDS980470D;   xx)\tPRE OP KIT, REF DYKS1262A;   yy)\tPULMONARY SETUP KIT, REF DYNDA2648;   zz)\tPULMONARY SETUP KIT, REF DYNDA2648H;   aaa)\tREDDY JOINT BATH, REF MMJB001;   bbb)\tREDDY JOINT BATH, REF MMJB001A;   ccc)\tRNSG 1441, REF EDUC1029;   ddd)\tRNSG 1441, REF EDUC1029H;   eee)\tRNSG 2201, REF EDUC1034;   fff)\tRNSG 2201, REF EDUC1034H;   ggg)\tSENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;   hhh)\tSHEATH REMOVAL TRAY, REF DYNDC1311C;   iii)\tSHORT TERM KIT, REF DYNDC3092;   jjj)\tSINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;   kkk)\tSTERILE CAP CHANGE, REF DYNDA2387A;   lll)\tSTERILE PREP KIT, REF DYNDA1359;   mmm)\tSTERILE PREP KIT, REF DYNDA1359A;   nnn)\tSTRL EK SINGLE PACK, REF DYNDA1360B;   ooo)\tSUB PORT ACCESS TRAY, REF DYNDC2768A;   ppp)\tSUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;   qqq)\tSURGICAL PREP KIT, REF DYNJ46340B;   rrr)\tSUTURE KIT, REF M101494;   sss)\tSUTURE TRAY, REF DYNDS1085A;   ttt)\tTRUNK KIT, REF DYKTRUNK1;   uuu)\tTRUNK KIT 1EA, REF DYKM2013;   vvv)\tUMBILICAL VESSEL INSERTION, REF DYNDA3011;   www)\tURINALYSIS KIT, REF DYKM1251;   xxx)\tVAD ACCESS CHANGE KIT, REF DYNDC2882B;   yyy)\tVAD DRESSING KIT A, REF DYNDA2164;   zzz)      CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;   aaaa)   CVC DRESSING CHANGE KIT, REF EBSI1552;   bbbb)   PORT ACCESS POWER LOC KIT, REF DYNDC1712B;   cccc)     PORT ACCESS TRAY, REF DYNDC1128B; — reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers:  23ALA126;   b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers:  22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554, 23FLA005;   c) REF DYKM1880, UDI/DI 40193489807524 (case), 10193489807523 (unit), Lot Numbers:  22FLA285, 23FLA657, 23HLA920;     d) REF DYKE1601, UDI/DI 40889942956082  (case), 10889942956081 (unit), Lot Numbers:  23ABG889, 23BBN595, 23BBU202, 23FBA860, 23HBI592;   e) REF DYNDH1242, UDI/DI 40889942598138 (case), 10889942598137 (unit), Lot Numbers:  22GLA574, 22KLA372, 22LLA696, 23ALA194, 23BLA985, 23CLA356, 23ELA844, 23FLA654, 23GLB027, 23HLA029, 23ILA700, 23JLB281;   f) REF DYKE1840, UDI/DI 40195327105649 (case), 10195327105648 (unit), Lot Numbers:   22BBT072, 22EBU502, 22KBM213, 22LBH747;   g) REF DYNJ37775F, UDI/DI 40888277906182  (case), 10888277906181 (unit), Lot Numbers:  22FDB681, 23ADC041, 23HDA605;   h) REF DYNDL1350A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers:  22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916;   i) REF DYNDL1350AH, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers:  22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916;   j) REF DYNDA2277A, UDI/DI 40195327004423 (case), 10195327003944 (unit), Lot Numbers:  21LBS528, 22ABD844, 22BBE910;   k) REF DYNDA2277B, UDI/DI UDI/DI  40195327120796 (case), 10195327120795 (unit), Lot Numbers:  22CBP893, 22DBQ630, 22IBG117;   l) REF DYNDC3006, UDI/DI 40193489421256 (case), 10193489421255 (unit), Lot Numbers:  22EBO159;    m) REF DYNDJ1076, UDI/DI 40889942790617 (Case), 10889942790616 (unit), Lot Numbers:  22IBS404, 23BBU808, 23FBQ938;   n) REF DT21230A, UDI/DI 40653160991503 (case), 10653160991502 (unit), Lot Numbers:   21LBS504, 22ABZ147, 22CBX302, 22DBD319, 22HBU059, 22IBG323;   o) REF DT20350B, UDI/DI 40653160991558 (case), 10653160991557 (unit), Lot Numbers; :  21LBT644, 22ABJ769, 22ABN465, 22ABU739, 22DBE295, 22GBD122, 22IBG207;   p) REF DT20355B, UDI/DI 40653160991541 (case), 10653160991540 (unit), Lot Numbers: 22BBR313, 22DBG177, 22IBB820, 22IBG220;   q) REF DYNDC2843, UDI/DI 40193489342575 (case), 10193489342574 (unit), Lot Numbers:  22ABB003, 22CBZ660, 22GBA430;   r) REF DYNJ68068A, UDI/DI 40193489880190 (case), 10193489880199 (unit), Lot Numbers:  21LBS172, 21LBS192, 22DBE425, 22IBS035, 22KBR704, 22OBD030, 22OBD031;   s) REF DYNJ68068B, UDI/DI 40195327306503 (case), 10195327306502 (unit), Lot Numbers:  23ABR366, 23CBT225, 23DBF157, 23HBI634, 23IBB018;   t) REF DYNJ51294, UDI/DI 40889942148098 (case), 10889942148097 (unit), Lot Numbers:  22ABA731, 22ABU356, 22EBQ983, 23EBL823;   u) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers:   22BLA237, 22BLA491, 22DLA830, 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478;   v) REF UVT1165, UDI/DI 40653160992319 (case), 10653160992318 (unit), Lot Numbers:   22EBE234, 22EBI596, 22OBD981;   w) REF DYKE1069B, UDI/DI 40889942907169 (case), 10889942907168 (unit), Lot Numbers:  21LBJ553, 22ABO501, 23FBA549;   x) REF DYKE1475B, UDI/DI 40889942893721 (case), 10889942893720 (unit), Lot Numbers:  22HDA831  y) REF P604360B, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers:  22KLA323, 22LLA144, 23ELB061;     z) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers:   22FLA082;   aa) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers:  22EBM568, 22EBV274, 22LBP469, 23CBV507, 23DBT035, 23GBU056, 23JBR179;   bb) REF EDUC1037, UDI/DI 40195327372331 (case), 10195327372330 (unit), Lot Numbers:  23DDA939, 23EDA052, 23EDB633;   cc) REF MNS13545, UDI/DI 40653160991886 (case), 10653160991885 (unit), Lot Numbers:   21LBS695, 22CBE432, 22CBO137, 22OBC049;   dd) REF CDS982759, UDI/DI 40884389451039 (case), 10884389451038 (unit), Lot Numbers:  22HBS221, 22KBB842, 22KBM294, 23DBL304, 23JBR357;   ee) REF DYNDV2330B, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers:  21LBT031, 22OBL922;   ff) REF DYNDV2330C, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers:  22OBL927;   gg) REF DYNJ38541B, UDI/DI 40888277543974 (case), 10888277543973 (unit), Lot Numbers:  22FLA088, 22GLA360, 23CLA092, 23ELA016, 23FLA996;   hh) REF DYKE1254C, UDI/DI 40889942782582 (case), 10889942782581 (unit), Lot Numbers:  22EDB717  ii) REF DYKM1883, UDI/DI 40193489234207 (case), 10193489234206 (unit), Lot Numbers:   22FBM572, 22FBR108, 22FBW122, 22HBF886;   jj) REF EDUC05059A, UDI/DI 40195327203888 (case), 10195327203887 (unit), Lot Numbers:  23DLA805, 23ELA502, 23ELA556, 23ELB066, 23ELB153;   kk) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers:  22ABA994;   ll) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers:   22BLA697, 22CLA586. 22GLA027;   mm) REF PHS422216004C, UDI/DI 10653160193081 (case), 00653160193084 (unit), Lot Numbers:  22OBG190, 22OBH215, 23EBS025, 23GBA226;   nn) REF UROT1051, UDI/DI 40888277791764 (case), 10888277791763 (unit), Lot Numbers:  22BBA990, 22CBC606, 22DBQ612;   oo) REF UROT1051A, UDI/DI40195327265992 (case), 10195327265991 (unit), Lot Numbers:  22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988;   pp) REF UROT1051AH, UDI/DI 40195327265992 (case), 10195327265991 (unit), Lot Numbers:  22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988;   qq) REF DYNDA2072A, UDI/DI 40193489586894 (case), 10193489586893 (unit). Lot Numbers:  22EBB022, 22FBN102, 22HBB085, 22KBG396, 22KBV529, 22LBJ527, 23EBC809, 23HBW281, 23IBR346;    rr) REF DYNDA2390A, UDI/DI 40195327025671 (case), 10195327025670 (unit), Lot Numbers:  22MBA027;   ss) REF DYK1188079W, UDI/DI 40080196854401 (case), 10080196854400 (unit), Lot Numbers:  22FBB386, 22HBU679, 22IBS684, 22LBD220, 23EBE385, 23FBJ776;   tt) REF EDUC05036, UDI/DI 40193489846370 (case), 10193489846379 (unit), Lot Numbers:  22FLA555, 22KLA681, 23BLA125, 23BLA486, 23CLA375, 23CLA977, 23CLB254, 23DLA481, 23ELA396, 23FLA274, 23GLA325, 23HLA852, 23HLA997, 23JLA948, 23JLA949;  uu) REF DYKM1872A, UDI/DI 40193489905404 (case), 10193489905403 (unit), Lot Numbers:  22IBV070, 22KBB323, 22KBE868, 23BBA791;   vv) REF EDUC05015A, UDI/DI 40193489849036 (case), 10193489849035 (unit), Lot Numbers:  22FDB801, 22KDA995, 23FDB243;   ww) REF CDS980470D, UDI/DI 40889942965046 (case), 10889942965045 (unit), Lot Numbers:  22IBU333;   xx) REF DYKS1262A, UDI/DI 40193489481854 (case), 10193489481853 (unit), Lot Numbers:  22DMG419, 22EMH939, 22LMF533;   yy) REF DYNDA2648, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers:  22GBO511, 22IBH087, 22JBI924;   zz) REF DYNDA2648H, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers:  22GBO511, 22IBH087, 22JBI924;   aaa) REF MMJB001, UDI/DI 40888277780553 (case), 10888277780552 (unit), Lot Numbers:  22DBO120, 22GBT358, 22JBV937, 22KBU083, 23ABL640, 23BBP851, 23DBD413;   bbb) REF MMJB001A, UDI/DI 40195327514878 (case), 10195327514877 (unit), Lot Numbers:  23JBD137;   ccc) REF EDUC1029, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers:  23CLA441, 23DLB129;   ddd) REF EDUC1029H, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers:  23CLA441, 23DLB129;   eee) REF EDUC1034, UDI/DI 40195327318940 (case)  10195327318949 (unit), Lot Numbers:  23CLA376;   fff) REF EDUC1034H, UDI/DI 40195327318940 (case), 10195327318949 (unit), Lot Numbers:  23CLA376;   ggg) REF DYNDC3185, UDI/DI 40195327034109 (case), 10195327034108 (unit), Lot Numbers:  23BBK719, 23CBM278, 23DBF310, 23DBN505, 23EBC880, 23EBU809;   hhh) REF DYNDC1311C, UDI/DI 40080196151562 (case), 10080196151561 (unit), Lot Numbers:  22EBB019, 22IBB934, 23CBN984;   iii) REF DYNDC3092, UDI/DI 40193489878500 (case), 10193489878509 (unit), Lot Numbers:  22ABZ049, 22HBS850, 22IBG383;   jjj) REF DYNDC2841, UDI/DI 40193489364676 (case), 10193489364675 (unit), Lot Numbers:  22ABB008, 22CBX108, 22CBY133, 22CBZ300, 22DBP299, 22IBA926, 22IBG249;   kkk) REF DYNDA2387A, UDI/DI 40195327025077 (case), 10195327025076 (unit), Lot Numbers:  22BBW633, 22DBD284, 22HBH277, 22IBI878;   lll) REF DYNDA1359, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers:  22GBI645, 22IBP085, 22KBH590, 22KBV524;    mmm) REF DYNDA1359A, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers:  23FBK812, 23FBP270, 23HBV043, 23IBN603;   nnn) REF DYNDA1360B, UDI/DI 40889942903864 (case), 10889942903863 (unit), Lot Numbers:  22EBN763, 22KBN275, 23BBF919, 23EBR548, 23HBM494;   ooo) REF DYNDC2768A, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers:  22ABJ771, 22DBB123;   ppp) REF DYNDT1019, UDI/DI 40080196954316 (case), 10080196954315 (unit), Lot Numbers:  22EBB037, 22GLA426, 22GLA485, 22HLA020, 22HLA318, 22HLA933;   qqq) REF DYNJ46340B, UDI/DI 40193489267502 (case), 10193489267501 (unit), Lot Numbers:  22EBG807, 22JBI745, 22KBO369, 23BBC803, 23DBD059, 23GBT971, 23HBK037;   rrr) REF M101494, UDI/DI 40193489215268 (case), 10193489215267 (unit), Lot Numbers:  22EBB001, 22FBW213, 22GBA533, 22IBH767, 22JBR552, 23ABH794, 23ABO157, 23BBD517, 23CBT240, 23DBS004, 23FBF076, 23GBW208;   sss) REF DYNDS1085A, UDI/DI 40080196778692 (case), 10080196778690 (unit), Lot Numbers:  22GBD145, 22GBT473, 22HBW597, 22JBQ784, 22LBK199, 23DBF574, 23EBB065, 23FBI285;   ttt) REF DYKTRUNK1, UDI/DI 40888277572196 (case), 10888277572195 (unit), Lot Numbers:  22IBB692, 22IBT561, 22KBN272, 22KBN273;   uuu) REF DYKM2013, UDI/DI 40193489796583 (case), 10193489796582 (unit), Lot Numbers:  23ABB515, 23CBM980;   vvv) REF DYNDA3011, UDI/DI 40195327283231 (case), 10195327283230 (unit), Lot Numbers:  23ABV484, 23BBS928, 23CBF143, 23CBP415;   www) REF DYKM1251, UDI/DI 40889942146445 (case), 10889942146444 (unit), Lot Numbers:  22MBA574, 23JBO199;   xxx) REF DYNDC2882B, UDI/DI 40193489417105 (case), 10193489417104 (unit), Lot Numbers:  22CBS826, 22IBG358, 22MBA772;   yyy) REF DYNDA2164, UDI/DI 40889942789642 (case), 10889942789641 (unit), Lot Numbers:  22ABG432, 22ABU607, 22DBG204, 22IBG168, 22JBG542, 23ABC729, 23BBN712, 23CBM329, 23EBU380;   zzz)     REF DYNDH1342B, UDI/DI 20193489111900 (case), 10193489111903 (unit), Lot Numbers:  2022042580;   aaaa)    REF EBSI1552, UDI/DI 00653160352320 (case), 10653160352327 (unit), Lot Numbers:  2022061380;   bbbb)    REF DYNDC1712B, UDI/DI 40888277279415 (case), 10888277279414 (unit), Lot Numbers:  2022032180;   cccc)     REF DYNDC1128B, UDI/DI 40888277950802 (case), 10888277950801 (unit), Lot Numbers:  2022032850, 2022050450. 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-1111-2024&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-1111-2024&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-1111-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1111-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-1111-2024&lang=eng",
        "value": "Class I",
        "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-1111-2024&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-1111-2024/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-1111-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1111-2024",
            "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 I",
            "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": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-15",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers:  23ALA126;   b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers:  22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554, 23FLA005;   c) REF DYKM1880, UDI/DI 40193489807524 (case), 10193489807523 (unit), Lot Numbers:  22FLA285, 23FLA657, 23HLA920;     d) REF DYKE1601, UDI/DI 40889942956082  (case), 10889942956081 (unit), Lot Numbers:  23ABG889, 23BBN595, 23BBU202, 23FBA860, 23HBI592;   e) REF DYNDH1242, UDI/DI 40889942598138 (case), 10889942598137 (unit), Lot Numbers:  22GLA574, 22KLA372, 22LLA696, 23ALA194, 23BLA985, 23CLA356, 23ELA844, 23FLA654, 23GLB027, 23HLA029, 23ILA700, 23JLB281;   f) REF DYKE1840, UDI/DI 40195327105649 (case), 10195327105648 (unit), Lot Numbers:   22BBT072, 22EBU502, 22KBM213, 22LBH747;   g) REF DYNJ37775F, UDI/DI 40888277906182  (case), 10888277906181 (unit), Lot Numbers:  22FDB681, 23ADC041, 23HDA605;   h) REF DYNDL1350A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers:  22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916;   i) REF DYNDL1350AH, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers:  22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916;   j) REF DYNDA2277A, UDI/DI 40195327004423 (case), 10195327003944 (unit), Lot Numbers:  21LBS528, 22ABD844, 22BBE910;   k) REF DYNDA2277B, UDI/DI UDI/DI  40195327120796 (case), 10195327120795 (unit), Lot Numbers:  22CBP893, 22DBQ630, 22IBG117;   l) REF DYNDC3006, UDI/DI 40193489421256 (case), 10193489421255 (unit), Lot Numbers:  22EBO159;    m) REF DYNDJ1076, UDI/DI 40889942790617 (Case), 10889942790616 (unit), Lot Numbers:  22IBS404, 23BBU808, 23FBQ938;   n) REF DT21230A, UDI/DI 40653160991503 (case), 10653160991502 (unit), Lot Numbers:   21LBS504, 22ABZ147, 22CBX302, 22DBD319, 22HBU059, 22IBG323;   o) REF DT20350B, UDI/DI 40653160991558 (case), 10653160991557 (unit), Lot Numbers; :  21LBT644, 22ABJ769, 22ABN465, 22ABU739, 22DBE295, 22GBD122, 22IBG207;   p) REF DT20355B, UDI/DI 40653160991541 (case), 10653160991540 (unit), Lot Numbers: 22BBR313, 22DBG177, 22IBB820, 22IBG220;   q) REF DYNDC2843, UDI/DI 40193489342575 (case), 10193489342574 (unit), Lot Numbers:  22ABB003, 22CBZ660, 22GBA430;   r) REF DYNJ68068A, UDI/DI 40193489880190 (case), 10193489880199 (unit), Lot Numbers:  21LBS172, 21LBS192, 22DBE425, 22IBS035, 22KBR704, 22OBD030, 22OBD031;   s) REF DYNJ68068B, UDI/DI 40195327306503 (case), 10195327306502 (unit), Lot Numbers:  23ABR366, 23CBT225, 23DBF157, 23HBI634, 23IBB018;   t) REF DYNJ51294, UDI/DI 40889942148098 (case), 10889942148097 (unit), Lot Numbers:  22ABA731, 22ABU356, 22EBQ983, 23EBL823;   u) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers:   22BLA237, 22BLA491, 22DLA830, 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478;   v) REF UVT1165, UDI/DI 40653160992319 (case), 10653160992318 (unit), Lot Numbers:   22EBE234, 22EBI596, 22OBD981;   w) REF DYKE1069B, UDI/DI 40889942907169 (case), 10889942907168 (unit), Lot Numbers:  21LBJ553, 22ABO501, 23FBA549;   x) REF DYKE1475B, UDI/DI 40889942893721 (case), 10889942893720 (unit), Lot Numbers:  22HDA831  y) REF P604360B, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers:  22KLA323, 22LLA144, 23ELB061;     z) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers:   22FLA082;   aa) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers:  22EBM568, 22EBV274, 22LBP469, 23CBV507, 23DBT035, 23GBU056, 23JBR179;   bb) REF EDUC1037, UDI/DI 40195327372331 (case), 10195327372330 (unit), Lot Numbers:  23DDA939, 23EDA052, 23EDB633;   cc) REF MNS13545, UDI/DI 40653160991886 (case), 10653160991885 (unit), Lot Numbers:   21LBS695, 22CBE432, 22CBO137, 22OBC049;   dd) REF CDS982759, UDI/DI 40884389451039 (case), 10884389451038 (unit), Lot Numbers:  22HBS221, 22KBB842, 22KBM294, 23DBL304, 23JBR357;   ee) REF DYNDV2330B, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers:  21LBT031, 22OBL922;   ff) REF DYNDV2330C, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers:  22OBL927;   gg) REF DYNJ38541B, UDI/DI 40888277543974 (case), 10888277543973 (unit), Lot Numbers:  22FLA088, 22GLA360, 23CLA092, 23ELA016, 23FLA996;   hh) REF DYKE1254C, UDI/DI 40889942782582 (case), 10889942782581 (unit), Lot Numbers:  22EDB717  ii) REF DYKM1883, UDI/DI 40193489234207 (case), 10193489234206 (unit), Lot Numbers:   22FBM572, 22FBR108, 22FBW122, 22HBF886;   jj) REF EDUC05059A, UDI/DI 40195327203888 (case), 10195327203887 (unit), Lot Numbers:  23DLA805, 23ELA502, 23ELA556, 23ELB066, 23ELB153;   kk) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers:  22ABA994;   ll) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers:   22BLA697, 22CLA586. 22GLA027;   mm) REF PHS422216004C, UDI/DI 10653160193081 (case), 00653160193084 (unit), Lot Numbers:  22OBG190, 22OBH215, 23EBS025, 23GBA226;   nn) REF UROT1051, UDI/DI 40888277791764 (case), 10888277791763 (unit), Lot Numbers:  22BBA990, 22CBC606, 22DBQ612;   oo) REF UROT1051A, UDI/DI40195327265992 (case), 10195327265991 (unit), Lot Numbers:  22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988;   pp) REF UROT1051AH, UDI/DI 40195327265992 (case), 10195327265991 (unit), Lot Numbers:  22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988;   qq) REF DYNDA2072A, UDI/DI 40193489586894 (case), 10193489586893 (unit). Lot Numbers:  22EBB022, 22FBN102, 22HBB085, 22KBG396, 22KBV529, 22LBJ527, 23EBC809, 23HBW281, 23IBR346;    rr) REF DYNDA2390A, UDI/DI 40195327025671 (case), 10195327025670 (unit), Lot Numbers:  22MBA027;   ss) REF DYK1188079W, UDI/DI 40080196854401 (case), 10080196854400 (unit), Lot Numbers:  22FBB386, 22HBU679, 22IBS684, 22LBD220, 23EBE385, 23FBJ776;   tt) REF EDUC05036, UDI/DI 40193489846370 (case), 10193489846379 (unit), Lot Numbers:  22FLA555, 22KLA681, 23BLA125, 23BLA486, 23CLA375, 23CLA977, 23CLB254, 23DLA481, 23ELA396, 23FLA274, 23GLA325, 23HLA852, 23HLA997, 23JLA948, 23JLA949;  uu) REF DYKM1872A, UDI/DI 40193489905404 (case), 10193489905403 (unit), Lot Numbers:  22IBV070, 22KBB323, 22KBE868, 23BBA791;   vv) REF EDUC05015A, UDI/DI 40193489849036 (case), 10193489849035 (unit), Lot Numbers:  22FDB801, 22KDA995, 23FDB243;   ww) REF CDS980470D, UDI/DI 40889942965046 (case), 10889942965045 (unit), Lot Numbers:  22IBU333;   xx) REF DYKS1262A, UDI/DI 40193489481854 (case), 10193489481853 (unit), Lot Numbers:  22DMG419, 22EMH939, 22LMF533;   yy) REF DYNDA2648, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers:  22GBO511, 22IBH087, 22JBI924;   zz) REF DYNDA2648H, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers:  22GBO511, 22IBH087, 22JBI924;   aaa) REF MMJB001, UDI/DI 40888277780553 (case), 10888277780552 (unit), Lot Numbers:  22DBO120, 22GBT358, 22JBV937, 22KBU083, 23ABL640, 23BBP851, 23DBD413;   bbb) REF MMJB001A, UDI/DI 40195327514878 (case), 10195327514877 (unit), Lot Numbers:  23JBD137;   ccc) REF EDUC1029, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers:  23CLA441, 23DLB129;   ddd) REF EDUC1029H, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers:  23CLA441, 23DLB129;   eee) REF EDUC1034, UDI/DI 40195327318940 (case)  10195327318949 (unit), Lot Numbers:  23CLA376;   fff) REF EDUC1034H, UDI/DI 40195327318940 (case), 10195327318949 (unit), Lot Numbers:  23CLA376;   ggg) REF DYNDC3185, UDI/DI 40195327034109 (case), 10195327034108 (unit), Lot Numbers:  23BBK719, 23CBM278, 23DBF310, 23DBN505, 23EBC880, 23EBU809;   hhh) REF DYNDC1311C, UDI/DI 40080196151562 (case), 10080196151561 (unit), Lot Numbers:  22EBB019, 22IBB934, 23CBN984;   iii) REF DYNDC3092, UDI/DI 40193489878500 (case), 10193489878509 (unit), Lot Numbers:  22ABZ049, 22HBS850, 22IBG383;   jjj) REF DYNDC2841, UDI/DI 40193489364676 (case), 10193489364675 (unit), Lot Numbers:  22ABB008, 22CBX108, 22CBY133, 22CBZ300, 22DBP299, 22IBA926, 22IBG249;   kkk) REF DYNDA2387A, UDI/DI 40195327025077 (case), 10195327025076 (unit), Lot Numbers:  22BBW633, 22DBD284, 22HBH277, 22IBI878;   lll) REF DYNDA1359, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers:  22GBI645, 22IBP085, 22KBH590, 22KBV524;    mmm) REF DYNDA1359A, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers:  23FBK812, 23FBP270, 23HBV043, 23IBN603;   nnn) REF DYNDA1360B, UDI/DI 40889942903864 (case), 10889942903863 (unit), Lot Numbers:  22EBN763, 22KBN275, 23BBF919, 23EBR548, 23HBM494;   ooo) REF DYNDC2768A, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers:  22ABJ771, 22DBB123;   ppp) REF DYNDT1019, UDI/DI 40080196954316 (case), 10080196954315 (unit), Lot Numbers:  22EBB037, 22GLA426, 22GLA485, 22HLA020, 22HLA318, 22HLA933;   qqq) REF DYNJ46340B, UDI/DI 40193489267502 (case), 10193489267501 (unit), Lot Numbers:  22EBG807, 22JBI745, 22KBO369, 23BBC803, 23DBD059, 23GBT971, 23HBK037;   rrr) REF M101494, UDI/DI 40193489215268 (case), 10193489215267 (unit), Lot Numbers:  22EBB001, 22FBW213, 22GBA533, 22IBH767, 22JBR552, 23ABH794, 23ABO157, 23BBD517, 23CBT240, 23DBS004, 23FBF076, 23GBW208;   sss) REF DYNDS1085A, UDI/DI 40080196778692 (case), 10080196778690 (unit), Lot Numbers:  22GBD145, 22GBT473, 22HBW597, 22JBQ784, 22LBK199, 23DBF574, 23EBB065, 23FBI285;   ttt) REF DYKTRUNK1, UDI/DI 40888277572196 (case), 10888277572195 (unit), Lot Numbers:  22IBB692, 22IBT561, 22KBN272, 22KBN273;   uuu) REF DYKM2013, UDI/DI 40193489796583 (case), 10193489796582 (unit), Lot Numbers:  23ABB515, 23CBM980;   vvv) REF DYNDA3011, UDI/DI 40195327283231 (case), 10195327283230 (unit), Lot Numbers:  23ABV484, 23BBS928, 23CBF143, 23CBP415;   www) REF DYKM1251, UDI/DI 40889942146445 (case), 10889942146444 (unit), Lot Numbers:  22MBA574, 23JBO199;   xxx) REF DYNDC2882B, UDI/DI 40193489417105 (case), 10193489417104 (unit), Lot Numbers:  22CBS826, 22IBG358, 22MBA772;   yyy) REF DYNDA2164, UDI/DI 40889942789642 (case), 10889942789641 (unit), Lot Numbers:  22ABG432, 22ABU607, 22DBG204, 22IBG168, 22JBG542, 23ABC729, 23BBN712, 23CBM329, 23EBU380;   zzz)     REF DYNDH1342B, UDI/DI 20193489111900 (case), 10193489111903 (unit), Lot Numbers:  2022042580;   aaaa)    REF EBSI1552, UDI/DI 00653160352320 (case), 10653160352327 (unit), Lot Numbers:  2022061380;   bbbb)    REF DYNDC1712B, UDI/DI 40888277279415 (case), 10888277279414 (unit), Lot Numbers:  2022032180;   cccc)     REF DYNDC1128B, UDI/DI 40888277950802 (case), 10888277950801 (unit), Lot Numbers:  2022032850, 2022050450",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}