{
  "@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-3027-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;   3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   5) PORT TRAY , Pack Number DT19245;   6) BIOPSY KIT, Pack Number DYNDA1466A;   7) BIOPSY KIT, Pack Number DYNDA1466A;   8) CATH REMOVAL, Pack Number DYNDA1733B;   9) CATH REMOVAL, Pack Number DYNDA1814;   10) CATH REMOVAL, Pack Number DYNDA1814;   11) CATH REMOVAL, Pack Number DYNDA1814;   12) CATH REMOVAL, Pack Number DYNDA1814;   13) CATH REMOVAL, Pack Number DYNDA1814;   14) CATH REMOVAL, Pack Number DYNDA1814;   15) CATH REMOVAL, Pack Number DYNDA1814;   16) CATH REMOVAL, Pack Number DYNDA1814;   17) SHUNT TRAY, Pack Number DYNDA2725;   18) PORT ACCESS KIT, Pack Number DYNDC2945;   19) PORT ACCESS KIT, Pack Number DYNDC2945;   20) PORT ACCESS KIT, Pack Number DYNDC2945;   21) PORT ACCESS KIT, Pack Number DYNDC2945;   22) PORT ACCESS KIT, Pack Number DYNDC2945;   23) PORT ACCESS KIT, Pack Number DYNDC2945;   24) PORT ACCESS KIT, Pack Number DYNDC2945;   25) PORT ACCESS KIT, Pack Number DYNDC2945;   26) PORT ACCESS KIT, Pack Number DYNDC2945;   27) PORT ACCESS KIT, Pack Number DYNDC2945;   28) ARTHROGRAM TRAY, Pack Number DYNDH1113;   29) BIOPSY TRAY, Pack Number DYNDH1137C;   30) BIOPSY PACK, Pack Number DYNDH1248;   31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   32) MYELOGRAM TRAY, Pack Number DYNDH1531;   33) BIOPSY PACK, Pack Number DYNDL1462B;   34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   36) PORT ACCESS TRAY, Pack Number EBSI1241;   37) PORT ACCESS TRAY, Pack Number EBSI1241;   38) PORT ACCESS TRAY, Pack Number EBSI1241;   39) PORT ACCESS TRAY, Pack Number EBSI1241;   40) PORT ACCESS TRAY, Pack Number EBSI1241;   41) PORT ACCESS TRAY, Pack Number EBSI1241;   42) PORT ACCESS TRAY, Pack Number EBSI1241;   43) PORT ACCESS TRAY, Pack Number EBSI1241;   44) PORT ACCESS TRAY, Pack Number EBSI1241;   45) PORT ACCESS TRAY, Pack Number EBSI1241;   46) PORT ACCESS TRAY, Pack Number EBSI1241;   47) PORT ACCESS TRAY, Pack Number EBSI1241;   48) PORT ACCESS TRAY, Pack Number EBSI1241;   49) PORT ACCESS TRAY, Pack Number EBSI1241;   50) PORT ACCESS TRAY, Pack Number EBSI1241;   51) PORT ACCESS TRAY, Pack Number EBSI1241;   52) PORT ACCESS TRAY, Pack Number EBSI1241;   53) PORT ACCESS TRAY, Pack Number EBSI1241;   54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   58) OB DELIVERY TRAY, Pack Number MNS10875A;   59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   60) OB DELIVERY SET, Pack Number MNS3355;   61) LUMBAR TRAY, Pack Number SPEC0177;   62) 22G FACET TRAY, Pack Number SPEC0265A;   63) FINE LACERATION KIT, Pack Number SUT19360;   64) LACERATION TRAY, Pack Number SUT20955;   65) LACERATION TRAY, Pack Number SUT3780;   66) LACERATION TRAY, Pack Number SUT3780;   67) SUTURING SET, Pack Number SUT4020",
  "description": "FDA recall Z-3027-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;   3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   5) PORT TRAY , Pack Number DT19245;   6) BIOPSY KIT, Pack Number DYNDA1466A;   7) BIOPSY KIT, Pack Number DYNDA1466A;   8) CATH REMOVAL, Pack Number DYNDA1733B;   9) CATH REMOVAL, Pack Number DYNDA1814;   10) CATH REMOVAL, Pack Number DYNDA1814;   11) CATH REMOVAL, Pack Number DYNDA1814;   12) CATH REMOVAL, Pack Number DYNDA1814;   13) CATH REMOVAL, Pack Number DYNDA1814;   14) CATH REMOVAL, Pack Number DYNDA1814;   15) CATH REMOVAL, Pack Number DYNDA1814;   16) CATH REMOVAL, Pack Number DYNDA1814;   17) SHUNT TRAY, Pack Number DYNDA2725;   18) PORT ACCESS KIT, Pack Number DYNDC2945;   19) PORT ACCESS KIT, Pack Number DYNDC2945;   20) PORT ACCESS KIT, Pack Number DYNDC2945;   21) PORT ACCESS KIT, Pack Number DYNDC2945;   22) PORT ACCESS KIT, Pack Number DYNDC2945;   23) PORT ACCESS KIT, Pack Number DYNDC2945;   24) PORT ACCESS KIT, Pack Number DYNDC2945;   25) PORT ACCESS KIT, Pack Number DYNDC2945;   26) PORT ACCESS KIT, Pack Number DYNDC2945;   27) PORT ACCESS KIT, Pack Number DYNDC2945;   28) ARTHROGRAM TRAY, Pack Number DYNDH1113;   29) BIOPSY TRAY, Pack Number DYNDH1137C;   30) BIOPSY PACK, Pack Number DYNDH1248;   31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   32) MYELOGRAM TRAY, Pack Number DYNDH1531;   33) BIOPSY PACK, Pack Number DYNDL1462B;   34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   36) PORT ACCESS TRAY, Pack Number EBSI1241;   37) PORT ACCESS TRAY, Pack Number EBSI1241;   38) PORT ACCESS TRAY, Pack Number EBSI1241;   39) PORT ACCESS TRAY, Pack Number EBSI1241;   40) PORT ACCESS TRAY, Pack Number EBSI1241;   41) PORT ACCESS TRAY, Pack Number EBSI1241;   42) PORT ACCESS TRAY, Pack Number EBSI1241;   43) PORT ACCESS TRAY, Pack Number EBSI1241;   44) PORT ACCESS TRAY, Pack Number EBSI1241;   45) PORT ACCESS TRAY, Pack Number EBSI1241;   46) PORT ACCESS TRAY, Pack Number EBSI1241;   47) PORT ACCESS TRAY, Pack Number EBSI1241;   48) PORT ACCESS TRAY, Pack Number EBSI1241;   49) PORT ACCESS TRAY, Pack Number EBSI1241;   50) PORT ACCESS TRAY, Pack Number EBSI1241;   51) PORT ACCESS TRAY, Pack Number EBSI1241;   52) PORT ACCESS TRAY, Pack Number EBSI1241;   53) PORT ACCESS TRAY, Pack Number EBSI1241;   54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   58) OB DELIVERY TRAY, Pack Number MNS10875A;   59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   60) OB DELIVERY SET, Pack Number MNS3355;   61) LUMBAR TRAY, Pack Number SPEC0177;   62) 22G FACET TRAY, Pack Number SPEC0265A;   63) FINE LACERATION KIT, Pack Number SUT19360;   64) LACERATION TRAY, Pack Number SUT20955;   65) LACERATION TRAY, Pack Number SUT3780;   66) LACERATION TRAY, Pack Number SUT3780;   67) SUTURING SET, Pack Number SUT4020 (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-3027-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;   3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   5) PORT TRAY , Pack Number DT19245;   6) BIOPSY KIT, Pack Number DYNDA1466A;   7) BIOPSY KIT, Pack Number DYNDA1466A;   8) CATH REMOVAL, Pack Number DYNDA1733B;   9) CATH REMOVAL, Pack Number DYNDA1814;   10) CATH REMOVAL, Pack Number DYNDA1814;   11) CATH REMOVAL, Pack Number DYNDA1814;   12) CATH REMOVAL, Pack Number DYNDA1814;   13) CATH REMOVAL, Pack Number DYNDA1814;   14) CATH REMOVAL, Pack Number DYNDA1814;   15) CATH REMOVAL, Pack Number DYNDA1814;   16) CATH REMOVAL, Pack Number DYNDA1814;   17) SHUNT TRAY, Pack Number DYNDA2725;   18) PORT ACCESS KIT, Pack Number DYNDC2945;   19) PORT ACCESS KIT, Pack Number DYNDC2945;   20) PORT ACCESS KIT, Pack Number DYNDC2945;   21) PORT ACCESS KIT, Pack Number DYNDC2945;   22) PORT ACCESS KIT, Pack Number DYNDC2945;   23) PORT ACCESS KIT, Pack Number DYNDC2945;   24) PORT ACCESS KIT, Pack Number DYNDC2945;   25) PORT ACCESS KIT, Pack Number DYNDC2945;   26) PORT ACCESS KIT, Pack Number DYNDC2945;   27) PORT ACCESS KIT, Pack Number DYNDC2945;   28) ARTHROGRAM TRAY, Pack Number DYNDH1113;   29) BIOPSY TRAY, Pack Number DYNDH1137C;   30) BIOPSY PACK, Pack Number DYNDH1248;   31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   32) MYELOGRAM TRAY, Pack Number DYNDH1531;   33) BIOPSY PACK, Pack Number DYNDL1462B;   34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   36) PORT ACCESS TRAY, Pack Number EBSI1241;   37) PORT ACCESS TRAY, Pack Number EBSI1241;   38) PORT ACCESS TRAY, Pack Number EBSI1241;   39) PORT ACCESS TRAY, Pack Number EBSI1241;   40) PORT ACCESS TRAY, Pack Number EBSI1241;   41) PORT ACCESS TRAY, Pack Number EBSI1241;   42) PORT ACCESS TRAY, Pack Number EBSI1241;   43) PORT ACCESS TRAY, Pack Number EBSI1241;   44) PORT ACCESS TRAY, Pack Number EBSI1241;   45) PORT ACCESS TRAY, Pack Number EBSI1241;   46) PORT ACCESS TRAY, Pack Number EBSI1241;   47) PORT ACCESS TRAY, Pack Number EBSI1241;   48) PORT ACCESS TRAY, Pack Number EBSI1241;   49) PORT ACCESS TRAY, Pack Number EBSI1241;   50) PORT ACCESS TRAY, Pack Number EBSI1241;   51) PORT ACCESS TRAY, Pack Number EBSI1241;   52) PORT ACCESS TRAY, Pack Number EBSI1241;   53) PORT ACCESS TRAY, Pack Number EBSI1241;   54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   58) OB DELIVERY TRAY, Pack Number MNS10875A;   59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   60) OB DELIVERY SET, Pack Number MNS3355;   61) LUMBAR TRAY, Pack Number SPEC0177;   62) 22G FACET TRAY, Pack Number SPEC0265A;   63) FINE LACERATION KIT, Pack Number SUT19360;   64) LACERATION TRAY, Pack Number SUT20955;   65) LACERATION TRAY, Pack Number SUT3780;   66) LACERATION TRAY, Pack Number SUT3780;   67) SUTURING SET, Pack Number SUT4020",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3027-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3027-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;   3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   5) PORT TRAY , Pack Number DT19245;   6) BIOPSY KIT, Pack Number DYNDA1466A;   7) BIOPSY KIT, Pack Number DYNDA1466A;   8) CATH REMOVAL, Pack Number DYNDA1733B;   9) CATH REMOVAL, Pack Number DYNDA1814;   10) CATH REMOVAL, Pack Number DYNDA1814;   11) CATH REMOVAL, Pack Number DYNDA1814;   12) CATH REMOVAL, Pack Number DYNDA1814;   13) CATH REMOVAL, Pack Number DYNDA1814;   14) CATH REMOVAL, Pack Number DYNDA1814;   15) CATH REMOVAL, Pack Number DYNDA1814;   16) CATH REMOVAL, Pack Number DYNDA1814;   17) SHUNT TRAY, Pack Number DYNDA2725;   18) PORT ACCESS KIT, Pack Number DYNDC2945;   19) PORT ACCESS KIT, Pack Number DYNDC2945;   20) PORT ACCESS KIT, Pack Number DYNDC2945;   21) PORT ACCESS KIT, Pack Number DYNDC2945;   22) PORT ACCESS KIT, Pack Number DYNDC2945;   23) PORT ACCESS KIT, Pack Number DYNDC2945;   24) PORT ACCESS KIT, Pack Number DYNDC2945;   25) PORT ACCESS KIT, Pack Number DYNDC2945;   26) PORT ACCESS KIT, Pack Number DYNDC2945;   27) PORT ACCESS KIT, Pack Number DYNDC2945;   28) ARTHROGRAM TRAY, Pack Number DYNDH1113;   29) BIOPSY TRAY, Pack Number DYNDH1137C;   30) BIOPSY PACK, Pack Number DYNDH1248;   31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   32) MYELOGRAM TRAY, Pack Number DYNDH1531;   33) BIOPSY PACK, Pack Number DYNDL1462B;   34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   36) PORT ACCESS TRAY, Pack Number EBSI1241;   37) PORT ACCESS TRAY, Pack Number EBSI1241;   38) PORT ACCESS TRAY, Pack Number EBSI1241;   39) PORT ACCESS TRAY, Pack Number EBSI1241;   40) PORT ACCESS TRAY, Pack Number EBSI1241;   41) PORT ACCESS TRAY, Pack Number EBSI1241;   42) PORT ACCESS TRAY, Pack Number EBSI1241;   43) PORT ACCESS TRAY, Pack Number EBSI1241;   44) PORT ACCESS TRAY, Pack Number EBSI1241;   45) PORT ACCESS TRAY, Pack Number EBSI1241;   46) PORT ACCESS TRAY, Pack Number EBSI1241;   47) PORT ACCESS TRAY, Pack Number EBSI1241;   48) PORT ACCESS TRAY, Pack Number EBSI1241;   49) PORT ACCESS TRAY, Pack Number EBSI1241;   50) PORT ACCESS TRAY, Pack Number EBSI1241;   51) PORT ACCESS TRAY, Pack Number EBSI1241;   52) PORT ACCESS TRAY, Pack Number EBSI1241;   53) PORT ACCESS TRAY, Pack Number EBSI1241;   54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   58) OB DELIVERY TRAY, Pack Number MNS10875A;   59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   60) OB DELIVERY SET, Pack Number MNS3355;   61) LUMBAR TRAY, Pack Number SPEC0177;   62) 22G FACET TRAY, Pack Number SPEC0265A;   63) FINE LACERATION KIT, Pack Number SUT19360;   64) LACERATION TRAY, Pack Number SUT20955;   65) LACERATION TRAY, Pack Number SUT3780;   66) LACERATION TRAY, Pack Number SUT3780;   67) SUTURING SET, Pack Number SUT4020",
      "text": "The FDA logged enforcement record Z-3027-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;   3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   5) PORT TRAY , Pack Number DT19245;   6) BIOPSY KIT, Pack Number DYNDA1466A;   7) BIOPSY KIT, Pack Number DYNDA1466A;   8) CATH REMOVAL, Pack Number DYNDA1733B;   9) CATH REMOVAL, Pack Number DYNDA1814;   10) CATH REMOVAL, Pack Number DYNDA1814;   11) CATH REMOVAL, Pack Number DYNDA1814;   12) CATH REMOVAL, Pack Number DYNDA1814;   13) CATH REMOVAL, Pack Number DYNDA1814;   14) CATH REMOVAL, Pack Number DYNDA1814;   15) CATH REMOVAL, Pack Number DYNDA1814;   16) CATH REMOVAL, Pack Number DYNDA1814;   17) SHUNT TRAY, Pack Number DYNDA2725;   18) PORT ACCESS KIT, Pack Number DYNDC2945;   19) PORT ACCESS KIT, Pack Number DYNDC2945;   20) PORT ACCESS KIT, Pack Number DYNDC2945;   21) PORT ACCESS KIT, Pack Number DYNDC2945;   22) PORT ACCESS KIT, Pack Number DYNDC2945;   23) PORT ACCESS KIT, Pack Number DYNDC2945;   24) PORT ACCESS KIT, Pack Number DYNDC2945;   25) PORT ACCESS KIT, Pack Number DYNDC2945;   26) PORT ACCESS KIT, Pack Number DYNDC2945;   27) PORT ACCESS KIT, Pack Number DYNDC2945;   28) ARTHROGRAM TRAY, Pack Number DYNDH1113;   29) BIOPSY TRAY, Pack Number DYNDH1137C;   30) BIOPSY PACK, Pack Number DYNDH1248;   31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;   32) MYELOGRAM TRAY, Pack Number DYNDH1531;   33) BIOPSY PACK, Pack Number DYNDL1462B;   34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;   36) PORT ACCESS TRAY, Pack Number EBSI1241;   37) PORT ACCESS TRAY, Pack Number EBSI1241;   38) PORT ACCESS TRAY, Pack Number EBSI1241;   39) PORT ACCESS TRAY, Pack Number EBSI1241;   40) PORT ACCESS TRAY, Pack Number EBSI1241;   41) PORT ACCESS TRAY, Pack Number EBSI1241;   42) PORT ACCESS TRAY, Pack Number EBSI1241;   43) PORT ACCESS TRAY, Pack Number EBSI1241;   44) PORT ACCESS TRAY, Pack Number EBSI1241;   45) PORT ACCESS TRAY, Pack Number EBSI1241;   46) PORT ACCESS TRAY, Pack Number EBSI1241;   47) PORT ACCESS TRAY, Pack Number EBSI1241;   48) PORT ACCESS TRAY, Pack Number EBSI1241;   49) PORT ACCESS TRAY, Pack Number EBSI1241;   50) PORT ACCESS TRAY, Pack Number EBSI1241;   51) PORT ACCESS TRAY, Pack Number EBSI1241;   52) PORT ACCESS TRAY, Pack Number EBSI1241;   53) PORT ACCESS TRAY, Pack Number EBSI1241;   54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;   56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;   58) OB DELIVERY TRAY, Pack Number MNS10875A;   59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   60) OB DELIVERY SET, Pack Number MNS3355;   61) LUMBAR TRAY, Pack Number SPEC0177;   62) 22G FACET TRAY, Pack Number SPEC0265A;   63) FINE LACERATION KIT, Pack Number SUT19360;   64) LACERATION TRAY, Pack Number SUT20955;   65) LACERATION TRAY, Pack Number SUT3780;   66) LACERATION TRAY, Pack Number SUT3780;   67) SUTURING SET, Pack Number SUT4020 — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: ART245C, Lot Number 2023083090;  CHT1900, Lot Number 2020092590;  CHT560, Lot Number 2020110590;  CHT705, Lot Number 2023011790;  DT19245        , Lot Number 21JBN311 ;  DYNDA1466A, Lot Number 2021111090;  DYNDA1466A, Lot Number 2023091890;  DYNDA1733B, Lot Number 2019021950;  DYNDA1814, Lot Number 2018103050;  DYNDA1814, Lot Number 2018121450;  DYNDA1814, Lot Number 2019010950;  DYNDA1814, Lot Number 2019021950;  DYNDA1814, Lot Number 2019041850;  DYNDA1814, Lot Number 2019112250;  DYNDA1814, Lot Number 2020031350;  DYNDA1814, Lot Number 2020100801;  DYNDA2725, Lot Number 2023011790;  DYNDC2945, Lot Number 2020071090;  DYNDC2945, Lot Number 2020090990;  DYNDC2945, Lot Number 2020110590;  DYNDC2945, Lot Number 2020122890;  DYNDC2945, Lot Number 2021081890;  DYNDC2945, Lot Number 2021120890;  DYNDC2945, Lot Number 2022121290;  DYNDC2945, Lot Number 2023011090;  DYNDC2945, Lot Number 2023080790;  DYNDC2945, Lot Number 2023091890;  DYNDH1113, Lot Number 2020031350;  DYNDH1137C, Lot Number 2021011890;  DYNDH1248, Lot Number 2019021950;  DYNDH1359, Lot Number 2023080790;  DYNDH1531, Lot Number 2022020990;  DYNDL1462B, Lot Number 2019010950;  EBSI1039B, Lot Number 2023083090;  EBSI1039B, Lot Number 2023110390;  EBSI1241, Lot Number 2019120590;  EBSI1241, Lot Number 2020040390;  EBSI1241, Lot Number 2020061990;  EBSI1241, Lot Number 2020092590;  EBSI1241, Lot Number 2020111390;  EBSI1241, Lot Number 2021011890;  EBSI1241, Lot Number 2021041290;  EBSI1241, Lot Number 2021091590;  EBSI1241, Lot Number 2021111090;  EBSI1241, Lot Number 2021120690;  EBSI1241, Lot Number 2022020990;  EBSI1241, Lot Number 2022042290;  EBSI1241, Lot Number 2022072690;  EBSI1241, Lot Number 2022082990;  EBSI1241, Lot Number 2022101390;  EBSI1241, Lot Number 2023011790;  EBSI1241, Lot Number 2023090690;  EBSI1241, Lot Number 2023110390;  EBSI1453, Lot Number 2022022180;  EBSI1453, Lot Number 2022032880;  EBSI1453A, Lot Number 2022093090;  EBSI1453A, Lot Number 2023083090;  MNS10875A, Lot Number 2023011790;  MNS12150, Lot Number 2022121290;  MNS3355, Lot Number 2020071090;  SPEC0177, Lot Number 2019120590;  SPEC0265A, Lot Number 2019120590;  SUT19360, Lot Number 2022042290;  SUT20955, Lot Number 2020092590;  SUT3780, Lot Number 2020061990;  SUT3780, Lot Number 2020111390;  SUT4020, Lot Number 2023091890. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
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        "value": "Devices recall, status Ongoing",
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          "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-3027-2024&lang=eng"
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      "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-3027-2024/fda-classification",
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      "name": "FDA classified recall Z-3027-2024 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.",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-3027-2024/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",
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
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