{
  "@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-1097-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "MEDLINE Kits, trays, and packs labeled as follows:    a)\tARTERIAL LINE PACK, REF DYNJ65208A;   b)\tCANCER SERVICE PORT KIT, REF DT22710;   c)\tCAP CHANGE KIT, REF DYNDC2002A;   d)\tCAP CHANGE KIT, REF DYNDC2723A;   e)\tCAP CHANGE KIT, REF DYNDC2723B;   f)\tCENTRAL LINE INSERTION PACK, REF CVI4805;   g)\tCENTRAL LINE TRAY, REF CVI4705;   h)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)\tCVC INSERTION PACK, REF CVI4720;   k)\tCVC INSERTION PACK, REF CVI4720A;   l)\tCVC INSERTION PACK, REF CVI4720AH;   m)\tDERM SURG CUSTOM PACK, REF DYNDA1584C;   n)\tER CENTRAL LINE KIT, REF P155508D;   o)\tFISTULA GRAFT KIT, REF DT20345A;   p)\tIMPLANTED PORT ACCESS, REF DYNDC2765B;   q)\tIVAD KIT, REF DYNDC2004B;   r)\tKIT LINE INSERTION, REF CVI4730H;   s)\tKIT LINE INSERTION, REF CVI4730;   t)\tLINE CHANGE KIT, REF DYNDC2927A;   u)\tMAX BARRIER PACK, REF DYNJ50717;   v)\tMEDIPORT W/CHG, REF DYNDC2219B;   w)\tMEDIPORT W/CHG, REF DYNDC2219BH;   x)\tNICU PICC INSERTION KIT, REF CVI4395B;   y)\tPACK,CENTRAL LINE, REF DYNJ906907B;   z)\tPEDI CENTRAL LINE AND PORT ACC, REF DT19740A;   aa)\tPEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636;   bb)\tPEDS/ NICU LINE KIT, REF MNS13555;   cc)\tPICC LINE PACK, REF DYNJ64249A;   dd)\tPICC LINE TRAY, REF DYNDC2170;   ee)\tPORT ACCESS KIT, REF DYNDC3251;   ff)\tPORT ACCESS KIT, REF DYNDC3251H;   gg)\tPORT ACCESS KIT, REF DYNDC3252;   hh)\tPORT ACCESS SUPPLIES, REF DYNDA2142B;   ii)\tPORT ACCESS TRAY, REF DYNDC2449B;   jj)\tPORT ACCESS TRAY, REF DYNDC3066;   kk)\tPORT ACCESS TRAY, REF DYNDC3103;   ll)\tPORT ACCESS/LAB KIT, REF DYNDC3129A;   mm)\tPORT ACCESS/LAB KIT, REF DYNDC3129AH;   nn)\tPORT FULL ACCESS TRAY, REF DT19330B;   oo)\tPORT KIT, REF DT22785;   pp)\tPORT KIT W/ HUBER NEEDLE, REF DT22780;   qq)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994C;   rr)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994D;   ss)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994DH;   tt)\tSUBCLAVIAN PORT ACCESS, REF DYNDC2555C;   uu)\tUSG PIV INSERTION KIT, REF DYNDV2480;   vv)\tUSG PIV INSERTION KIT, REF DYNDV2480H;   ww)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078;   xx)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078H;   yy)\tVAD DRESSING CHANGE TRAY, REF DYNDC2657A;   zz)\tVAD KIT WITHOUT VALVES, REF DYNDC3179;   aaa)  VEIN CLOSURE PACK, REF DYNJ69976",
  "description": "FDA recall Z-1097-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tARTERIAL LINE PACK, REF DYNJ65208A;   b)\tCANCER SERVICE PORT KIT, REF DT22710;   c)\tCAP CHANGE KIT, REF DYNDC2002A;   d)\tCAP CHANGE KIT, REF DYNDC2723A;   e)\tCAP CHANGE KIT, REF DYNDC2723B;   f)\tCENTRAL LINE INSERTION PACK, REF CVI4805;   g)\tCENTRAL LINE TRAY, REF CVI4705;   h)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)\tCVC INSERTION PACK, REF CVI4720;   k)\tCVC INSERTION PACK, REF CVI4720A;   l)\tCVC INSERTION PACK, REF CVI4720AH;   m)\tDERM SURG CUSTOM PACK, REF DYNDA1584C;   n)\tER CENTRAL LINE KIT, REF P155508D;   o)\tFISTULA GRAFT KIT, REF DT20345A;   p)\tIMPLANTED PORT ACCESS, REF DYNDC2765B;   q)\tIVAD KIT, REF DYNDC2004B;   r)\tKIT LINE INSERTION, REF CVI4730H;   s)\tKIT LINE INSERTION, REF CVI4730;   t)\tLINE CHANGE KIT, REF DYNDC2927A;   u)\tMAX BARRIER PACK, REF DYNJ50717;   v)\tMEDIPORT W/CHG, REF DYNDC2219B;   w)\tMEDIPORT W/CHG, REF DYNDC2219BH;   x)\tNICU PICC INSERTION KIT, REF CVI4395B;   y)\tPACK,CENTRAL LINE, REF DYNJ906907B;   z)\tPEDI CENTRAL LINE AND PORT ACC, REF DT19740A;   aa)\tPEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636;   bb)\tPEDS/ NICU LINE KIT, REF MNS13555;   cc)\tPICC LINE PACK, REF DYNJ64249A;   dd)\tPICC LINE TRAY, REF DYNDC2170;   ee)\tPORT ACCESS KIT, REF DYNDC3251;   ff)\tPORT ACCESS KIT, REF DYNDC3251H;   gg)\tPORT ACCESS KIT, REF DYNDC3252;   hh)\tPORT ACCESS SUPPLIES, REF DYNDA2142B;   ii)\tPORT ACCESS TRAY, REF DYNDC2449B;   jj)\tPORT ACCESS TRAY, REF DYNDC3066;   kk)\tPORT ACCESS TRAY, REF DYNDC3103;   ll)\tPORT ACCESS/LAB KIT, REF DYNDC3129A;   mm)\tPORT ACCESS/LAB KIT, REF DYNDC3129AH;   nn)\tPORT FULL ACCESS TRAY, REF DT19330B;   oo)\tPORT KIT, REF DT22785;   pp)\tPORT KIT W/ HUBER NEEDLE, REF DT22780;   qq)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994C;   rr)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994D;   ss)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994DH;   tt)\tSUBCLAVIAN PORT ACCESS, REF DYNDC2555C;   uu)\tUSG PIV INSERTION KIT, REF DYNDV2480;   vv)\tUSG PIV INSERTION KIT, REF DYNDV2480H;   ww)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078;   xx)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078H;   yy)\tVAD DRESSING CHANGE TRAY, REF DYNDC2657A;   zz)\tVAD KIT WITHOUT VALVES, REF DYNDC3179;   aaa)  VEIN CLOSURE PACK, REF DYNJ69976 (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-1097-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MEDLINE Kits, trays, and packs labeled as follows:    a)\tARTERIAL LINE PACK, REF DYNJ65208A;   b)\tCANCER SERVICE PORT KIT, REF DT22710;   c)\tCAP CHANGE KIT, REF DYNDC2002A;   d)\tCAP CHANGE KIT, REF DYNDC2723A;   e)\tCAP CHANGE KIT, REF DYNDC2723B;   f)\tCENTRAL LINE INSERTION PACK, REF CVI4805;   g)\tCENTRAL LINE TRAY, REF CVI4705;   h)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)\tCVC INSERTION PACK, REF CVI4720;   k)\tCVC INSERTION PACK, REF CVI4720A;   l)\tCVC INSERTION PACK, REF CVI4720AH;   m)\tDERM SURG CUSTOM PACK, REF DYNDA1584C;   n)\tER CENTRAL LINE KIT, REF P155508D;   o)\tFISTULA GRAFT KIT, REF DT20345A;   p)\tIMPLANTED PORT ACCESS, REF DYNDC2765B;   q)\tIVAD KIT, REF DYNDC2004B;   r)\tKIT LINE INSERTION, REF CVI4730H;   s)\tKIT LINE INSERTION, REF CVI4730;   t)\tLINE CHANGE KIT, REF DYNDC2927A;   u)\tMAX BARRIER PACK, REF DYNJ50717;   v)\tMEDIPORT W/CHG, REF DYNDC2219B;   w)\tMEDIPORT W/CHG, REF DYNDC2219BH;   x)\tNICU PICC INSERTION KIT, REF CVI4395B;   y)\tPACK,CENTRAL LINE, REF DYNJ906907B;   z)\tPEDI CENTRAL LINE AND PORT ACC, REF DT19740A;   aa)\tPEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636;   bb)\tPEDS/ NICU LINE KIT, REF MNS13555;   cc)\tPICC LINE PACK, REF DYNJ64249A;   dd)\tPICC LINE TRAY, REF DYNDC2170;   ee)\tPORT ACCESS KIT, REF DYNDC3251;   ff)\tPORT ACCESS KIT, REF DYNDC3251H;   gg)\tPORT ACCESS KIT, REF DYNDC3252;   hh)\tPORT ACCESS SUPPLIES, REF DYNDA2142B;   ii)\tPORT ACCESS TRAY, REF DYNDC2449B;   jj)\tPORT ACCESS TRAY, REF DYNDC3066;   kk)\tPORT ACCESS TRAY, REF DYNDC3103;   ll)\tPORT ACCESS/LAB KIT, REF DYNDC3129A;   mm)\tPORT ACCESS/LAB KIT, REF DYNDC3129AH;   nn)\tPORT FULL ACCESS TRAY, REF DT19330B;   oo)\tPORT KIT, REF DT22785;   pp)\tPORT KIT W/ HUBER NEEDLE, REF DT22780;   qq)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994C;   rr)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994D;   ss)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994DH;   tt)\tSUBCLAVIAN PORT ACCESS, REF DYNDC2555C;   uu)\tUSG PIV INSERTION KIT, REF DYNDV2480;   vv)\tUSG PIV INSERTION KIT, REF DYNDV2480H;   ww)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078;   xx)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078H;   yy)\tVAD DRESSING CHANGE TRAY, REF DYNDC2657A;   zz)\tVAD KIT WITHOUT VALVES, REF DYNDC3179;   aaa)  VEIN CLOSURE PACK, REF DYNJ69976",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1097-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1097-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tARTERIAL LINE PACK, REF DYNJ65208A;   b)\tCANCER SERVICE PORT KIT, REF DT22710;   c)\tCAP CHANGE KIT, REF DYNDC2002A;   d)\tCAP CHANGE KIT, REF DYNDC2723A;   e)\tCAP CHANGE KIT, REF DYNDC2723B;   f)\tCENTRAL LINE INSERTION PACK, REF CVI4805;   g)\tCENTRAL LINE TRAY, REF CVI4705;   h)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)\tCVC INSERTION PACK, REF CVI4720;   k)\tCVC INSERTION PACK, REF CVI4720A;   l)\tCVC INSERTION PACK, REF CVI4720AH;   m)\tDERM SURG CUSTOM PACK, REF DYNDA1584C;   n)\tER CENTRAL LINE KIT, REF P155508D;   o)\tFISTULA GRAFT KIT, REF DT20345A;   p)\tIMPLANTED PORT ACCESS, REF DYNDC2765B;   q)\tIVAD KIT, REF DYNDC2004B;   r)\tKIT LINE INSERTION, REF CVI4730H;   s)\tKIT LINE INSERTION, REF CVI4730;   t)\tLINE CHANGE KIT, REF DYNDC2927A;   u)\tMAX BARRIER PACK, REF DYNJ50717;   v)\tMEDIPORT W/CHG, REF DYNDC2219B;   w)\tMEDIPORT W/CHG, REF DYNDC2219BH;   x)\tNICU PICC INSERTION KIT, REF CVI4395B;   y)\tPACK,CENTRAL LINE, REF DYNJ906907B;   z)\tPEDI CENTRAL LINE AND PORT ACC, REF DT19740A;   aa)\tPEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636;   bb)\tPEDS/ NICU LINE KIT, REF MNS13555;   cc)\tPICC LINE PACK, REF DYNJ64249A;   dd)\tPICC LINE TRAY, REF DYNDC2170;   ee)\tPORT ACCESS KIT, REF DYNDC3251;   ff)\tPORT ACCESS KIT, REF DYNDC3251H;   gg)\tPORT ACCESS KIT, REF DYNDC3252;   hh)\tPORT ACCESS SUPPLIES, REF DYNDA2142B;   ii)\tPORT ACCESS TRAY, REF DYNDC2449B;   jj)\tPORT ACCESS TRAY, REF DYNDC3066;   kk)\tPORT ACCESS TRAY, REF DYNDC3103;   ll)\tPORT ACCESS/LAB KIT, REF DYNDC3129A;   mm)\tPORT ACCESS/LAB KIT, REF DYNDC3129AH;   nn)\tPORT FULL ACCESS TRAY, REF DT19330B;   oo)\tPORT KIT, REF DT22785;   pp)\tPORT KIT W/ HUBER NEEDLE, REF DT22780;   qq)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994C;   rr)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994D;   ss)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994DH;   tt)\tSUBCLAVIAN PORT ACCESS, REF DYNDC2555C;   uu)\tUSG PIV INSERTION KIT, REF DYNDV2480;   vv)\tUSG PIV INSERTION KIT, REF DYNDV2480H;   ww)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078;   xx)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078H;   yy)\tVAD DRESSING CHANGE TRAY, REF DYNDC2657A;   zz)\tVAD KIT WITHOUT VALVES, REF DYNDC3179;   aaa)  VEIN CLOSURE PACK, REF DYNJ69976",
      "text": "The FDA logged enforcement record Z-1097-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling MEDLINE Kits, trays, and packs labeled as follows:    a)\tARTERIAL LINE PACK, REF DYNJ65208A;   b)\tCANCER SERVICE PORT KIT, REF DT22710;   c)\tCAP CHANGE KIT, REF DYNDC2002A;   d)\tCAP CHANGE KIT, REF DYNDC2723A;   e)\tCAP CHANGE KIT, REF DYNDC2723B;   f)\tCENTRAL LINE INSERTION PACK, REF CVI4805;   g)\tCENTRAL LINE TRAY, REF CVI4705;   h)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A;   i)\tCNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B;   j)\tCVC INSERTION PACK, REF CVI4720;   k)\tCVC INSERTION PACK, REF CVI4720A;   l)\tCVC INSERTION PACK, REF CVI4720AH;   m)\tDERM SURG CUSTOM PACK, REF DYNDA1584C;   n)\tER CENTRAL LINE KIT, REF P155508D;   o)\tFISTULA GRAFT KIT, REF DT20345A;   p)\tIMPLANTED PORT ACCESS, REF DYNDC2765B;   q)\tIVAD KIT, REF DYNDC2004B;   r)\tKIT LINE INSERTION, REF CVI4730H;   s)\tKIT LINE INSERTION, REF CVI4730;   t)\tLINE CHANGE KIT, REF DYNDC2927A;   u)\tMAX BARRIER PACK, REF DYNJ50717;   v)\tMEDIPORT W/CHG, REF DYNDC2219B;   w)\tMEDIPORT W/CHG, REF DYNDC2219BH;   x)\tNICU PICC INSERTION KIT, REF CVI4395B;   y)\tPACK,CENTRAL LINE, REF DYNJ906907B;   z)\tPEDI CENTRAL LINE AND PORT ACC, REF DT19740A;   aa)\tPEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636;   bb)\tPEDS/ NICU LINE KIT, REF MNS13555;   cc)\tPICC LINE PACK, REF DYNJ64249A;   dd)\tPICC LINE TRAY, REF DYNDC2170;   ee)\tPORT ACCESS KIT, REF DYNDC3251;   ff)\tPORT ACCESS KIT, REF DYNDC3251H;   gg)\tPORT ACCESS KIT, REF DYNDC3252;   hh)\tPORT ACCESS SUPPLIES, REF DYNDA2142B;   ii)\tPORT ACCESS TRAY, REF DYNDC2449B;   jj)\tPORT ACCESS TRAY, REF DYNDC3066;   kk)\tPORT ACCESS TRAY, REF DYNDC3103;   ll)\tPORT ACCESS/LAB KIT, REF DYNDC3129A;   mm)\tPORT ACCESS/LAB KIT, REF DYNDC3129AH;   nn)\tPORT FULL ACCESS TRAY, REF DT19330B;   oo)\tPORT KIT, REF DT22785;   pp)\tPORT KIT W/ HUBER NEEDLE, REF DT22780;   qq)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994C;   rr)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994D;   ss)\tPORT-A-CATH ACCESS KIT, REF DYNDC1994DH;   tt)\tSUBCLAVIAN PORT ACCESS, REF DYNDC2555C;   uu)\tUSG PIV INSERTION KIT, REF DYNDV2480;   vv)\tUSG PIV INSERTION KIT, REF DYNDV2480H;   ww)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078;   xx)\tVAD DRESSING CHANGE TRAY, REF DYNDC2078H;   yy)\tVAD DRESSING CHANGE TRAY, REF DYNDC2657A;   zz)\tVAD KIT WITHOUT VALVES, REF DYNDC3179;   aaa)  VEIN CLOSURE PACK, REF DYNJ69976 — 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 DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers:  23CMB532, 23CME753, 23EMD721, 23FMH948;   b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers:    c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132;   d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers:  22ABH235, 22BBF113, 22IBG479;   e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers:  22ABZ109, 22BBK108;   f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers:  22ABP582, 22CBP735, 22JBK237, 22LBK168;   g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653;    h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers:  21LBK271, 22ABS686;   i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers:  22CBS571, 22DBO302, 22IBG350;   j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197;    k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187;   l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers:  23DLA715, 23ELB184, 23GLA187;   m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers:  22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230;   n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers:   22DMC487, 23AMB416, 23BMF491, 23FMD563;     o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers:   22ABJ804, 22BBA095, 22IBG184, 22OBE089;    p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers:  22ABJ710, 22CBV307, 22CBX726, 22OBA248;   q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers:  22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995;   r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers:  22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers:  22BBW666, 22HBT170;   u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers:  22ABY200, 22HBH109;    v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268;   y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers:  23BMF842;   z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers:   22EBE126, 22HBC049, 22IBG224;    aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers:  22BBG415, 22DBE305, 22MBA761;   bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers:  22CBE020, 22EBP942;   cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers:  22FLA161;   dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers:   22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576;   ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587;   ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587  gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers:  22IBG588;   hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers:  22DBG180, 22EMC030;   ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers:  21LBT939, 22EBP926, 22FBT224;   jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers:  22CBD170;   kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers:  22HBT222, 22IBG493, 22MBA063;   ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers:  22OBC582, 22OBE354;   oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers:  22CBP076, 22CBS504;   pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers:  22DBD209;   qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers:  22ABJ752, 22ABZ148, 22DBD308;   rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers:  22OBE207;   uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers:  22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804;   zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers:  22ABK983, 22ABO532;   aaa)  REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers:  22BBW440. 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-1097-2024&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-1097-2024&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-1097-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1097-2024 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-1097-2024&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-1097-2024&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-1097-2024/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-1097-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1097-2024",
            "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 DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers:  23CMB532, 23CME753, 23EMD721, 23FMH948;   b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers:    c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132;   d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers:  22ABH235, 22BBF113, 22IBG479;   e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers:  22ABZ109, 22BBK108;   f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers:  22ABP582, 22CBP735, 22JBK237, 22LBK168;   g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653;    h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers:  21LBK271, 22ABS686;   i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers:  22CBS571, 22DBO302, 22IBG350;   j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197;    k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187;   l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers:  23DLA715, 23ELB184, 23GLA187;   m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers:  22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230;   n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers:   22DMC487, 23AMB416, 23BMF491, 23FMD563;     o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers:   22ABJ804, 22BBA095, 22IBG184, 22OBE089;    p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers:  22ABJ710, 22CBV307, 22CBX726, 22OBA248;   q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers:  22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995;   r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers:  22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers:  22BBW666, 22HBT170;   u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers:  22ABY200, 22HBH109;    v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268;   y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers:  23BMF842;   z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers:   22EBE126, 22HBC049, 22IBG224;    aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers:  22BBG415, 22DBE305, 22MBA761;   bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers:  22CBE020, 22EBP942;   cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers:  22FLA161;   dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers:   22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576;   ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587;   ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587  gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers:  22IBG588;   hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers:  22DBG180, 22EMC030;   ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers:  21LBT939, 22EBP926, 22FBT224;   jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers:  22CBD170;   kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers:  22HBT222, 22IBG493, 22MBA063;   ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers:  22OBC582, 22OBE354;   oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers:  22CBP076, 22CBS504;   pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers:  22DBD209;   qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers:  22ABJ752, 22ABZ148, 22DBD308;   rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers:  22OBE207;   uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers:  22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804;   zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers:  22ABK983, 22ABO532;   aaa)  REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers:  22BBW440",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}