{
  "@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-2767-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Centurion procedure kits, labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) ARTHROGRAPH TRAY, Pack Number MNS12670A;   5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;   6) BIOPSY TRAY, Pack Number BT1060;   7) BIOPSY TRAY, Pack Number BT1015;   8) BIOPSY TRAY, Pack Number DYNDH1137C;   9) BIOPSY TRAY-LF, Pack Number SPEC4380;   10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;   11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   14) CIRCUMCISION TRAY, Pack Number CIT7050C;   15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;   16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;   17) ER CHEST TUBE TRAY, Pack Number CHT1570A;   18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;   20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;   21) LUMBAR PUNCTURE TRAY, Pack Number PT215;   22) LUMBAR TRAY, Pack Number SPEC0197B;   23) NICU PICC KIT, Pack Number CVI4575;   24) OB DELIVERY TRAY, Pack Number MNS10875A;   25) ON/OFF KIT, Pack Number DT8525;   26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;   27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;   28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;   29) PORT ACCESS KIT, Pack Number DYNDC2945;   30) PORT ACCESS TRAY, Pack Number EBSI1241;   31) PORT INSERTION KIT, Pack Number MNS11590;   32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   33) STEREOTACTIC TRAY, Pack Number MNS5785;   34) SUTURING SET, Pack Number SUT4020;   35) U.A.C. TRAY, Pack Number UVT125;   36) ULTRASOUND TRAY, Pack Number MNS5460;   37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;   38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
  "description": "FDA recall Z-2767-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits, labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) ARTHROGRAPH TRAY, Pack Number MNS12670A;   5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;   6) BIOPSY TRAY, Pack Number BT1060;   7) BIOPSY TRAY, Pack Number BT1015;   8) BIOPSY TRAY, Pack Number DYNDH1137C;   9) BIOPSY TRAY-LF, Pack Number SPEC4380;   10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;   11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   14) CIRCUMCISION TRAY, Pack Number CIT7050C;   15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;   16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;   17) ER CHEST TUBE TRAY, Pack Number CHT1570A;   18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;   20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;   21) LUMBAR PUNCTURE TRAY, Pack Number PT215;   22) LUMBAR TRAY, Pack Number SPEC0197B;   23) NICU PICC KIT, Pack Number CVI4575;   24) OB DELIVERY TRAY, Pack Number MNS10875A;   25) ON/OFF KIT, Pack Number DT8525;   26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;   27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;   28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;   29) PORT ACCESS KIT, Pack Number DYNDC2945;   30) PORT ACCESS TRAY, Pack Number EBSI1241;   31) PORT INSERTION KIT, Pack Number MNS11590;   32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   33) STEREOTACTIC TRAY, Pack Number MNS5785;   34) SUTURING SET, Pack Number SUT4020;   35) U.A.C. TRAY, Pack Number UVT125;   36) ULTRASOUND TRAY, Pack Number MNS5460;   37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;   38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A (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-2767-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centurion procedure kits, labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) ARTHROGRAPH TRAY, Pack Number MNS12670A;   5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;   6) BIOPSY TRAY, Pack Number BT1060;   7) BIOPSY TRAY, Pack Number BT1015;   8) BIOPSY TRAY, Pack Number DYNDH1137C;   9) BIOPSY TRAY-LF, Pack Number SPEC4380;   10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;   11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   14) CIRCUMCISION TRAY, Pack Number CIT7050C;   15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;   16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;   17) ER CHEST TUBE TRAY, Pack Number CHT1570A;   18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;   20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;   21) LUMBAR PUNCTURE TRAY, Pack Number PT215;   22) LUMBAR TRAY, Pack Number SPEC0197B;   23) NICU PICC KIT, Pack Number CVI4575;   24) OB DELIVERY TRAY, Pack Number MNS10875A;   25) ON/OFF KIT, Pack Number DT8525;   26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;   27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;   28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;   29) PORT ACCESS KIT, Pack Number DYNDC2945;   30) PORT ACCESS TRAY, Pack Number EBSI1241;   31) PORT INSERTION KIT, Pack Number MNS11590;   32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   33) STEREOTACTIC TRAY, Pack Number MNS5785;   34) SUTURING SET, Pack Number SUT4020;   35) U.A.C. TRAY, Pack Number UVT125;   36) ULTRASOUND TRAY, Pack Number MNS5460;   37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;   38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2767-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2767-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits, labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) ARTHROGRAPH TRAY, Pack Number MNS12670A;   5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;   6) BIOPSY TRAY, Pack Number BT1060;   7) BIOPSY TRAY, Pack Number BT1015;   8) BIOPSY TRAY, Pack Number DYNDH1137C;   9) BIOPSY TRAY-LF, Pack Number SPEC4380;   10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;   11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   14) CIRCUMCISION TRAY, Pack Number CIT7050C;   15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;   16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;   17) ER CHEST TUBE TRAY, Pack Number CHT1570A;   18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;   20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;   21) LUMBAR PUNCTURE TRAY, Pack Number PT215;   22) LUMBAR TRAY, Pack Number SPEC0197B;   23) NICU PICC KIT, Pack Number CVI4575;   24) OB DELIVERY TRAY, Pack Number MNS10875A;   25) ON/OFF KIT, Pack Number DT8525;   26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;   27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;   28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;   29) PORT ACCESS KIT, Pack Number DYNDC2945;   30) PORT ACCESS TRAY, Pack Number EBSI1241;   31) PORT INSERTION KIT, Pack Number MNS11590;   32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   33) STEREOTACTIC TRAY, Pack Number MNS5785;   34) SUTURING SET, Pack Number SUT4020;   35) U.A.C. TRAY, Pack Number UVT125;   36) ULTRASOUND TRAY, Pack Number MNS5460;   37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;   38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
      "text": "The FDA logged enforcement record Z-2767-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Centurion procedure kits, labeled as:    1) 6\" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;   2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) ARTHROGRAPH TRAY, Pack Number MNS12670A;   5) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;   6) BIOPSY TRAY, Pack Number BT1060;   7) BIOPSY TRAY, Pack Number BT1015;   8) BIOPSY TRAY, Pack Number DYNDH1137C;   9) BIOPSY TRAY-LF, Pack Number SPEC4380;   10) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;   11) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   12) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   13) CHEST TUBE INSERTION TRAY, Pack Number CHT560;   14) CIRCUMCISION TRAY, Pack Number CIT7050C;   15) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;   16) CVC INSERT BUNDLE 16CM, Pack Number ECVC7860;   17) ER CHEST TUBE TRAY, Pack Number CHT1570A;   18) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   19) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;   20) LOCAL INFILTRATION TRAY, Pack Number DYNDH1406;   21) LUMBAR PUNCTURE TRAY, Pack Number PT215;   22) LUMBAR TRAY, Pack Number SPEC0197B;   23) NICU PICC KIT, Pack Number CVI4575;   24) OB DELIVERY TRAY, Pack Number MNS10875A;   25) ON/OFF KIT, Pack Number DT8525;   26) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320;   27) PERIPHERAL BLOOD CULTURE KIT (1 SET), Pack Number DYNDH1910;   28) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560;   29) PORT ACCESS KIT, Pack Number DYNDC2945;   30) PORT ACCESS TRAY, Pack Number EBSI1241;   31) PORT INSERTION KIT, Pack Number MNS11590;   32) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   33) STEREOTACTIC TRAY, Pack Number MNS5785;   34) SUTURING SET, Pack Number SUT4020;   35) U.A.C. TRAY, Pack Number UVT125;   36) ULTRASOUND TRAY, Pack Number MNS5460;   37) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT1080;   38) UMBILICAL VESSEL TRAY, Pack Number UVT1100A;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020A — 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 2023101990;  ART1170, Lot Number 2022121990;  ART1170, Lot Number 2023012790;  ART1170, Lot Number 2023021590;  PT220, Lot Number 2021061490;  PT220, Lot Number 2022011090;  MNS12670A, Lot Number 2021060190;  MNS12670A, Lot Number 2022011090;  MNS12670A, Lot Number 2023022190;  MNS12670A, Lot Number 2023101890;  SUT20455, Lot Number 2021060190;  SUT20455, Lot Number 2022011090;  SUT20455, Lot Number 2023012390;  BT1060, Lot Number 2020062490;  BT1015, Lot Number 2021060190;  DYNDH1137C, Lot Number 2021091490;  DYNDH1137C, Lot Number 2022121990;  SPEC4380, Lot Number 2018102950;  SPEC4380, Lot Number 2023032390;  DYNJTS0214, Lot Number 2022061790;  DYNJTS0214, Lot Number 22121990;  SPEC0130C, Lot Number 2023022190;  S5078BF09, Lot Number 2020051850;  S5078BF09, Lot Number 2022092290;  CHT560, Lot Number 2018042790;  CHT560, Lot Number 2018050790;  CHT560, Lot Number 2018060490;  CHT560, Lot Number 2018080790;  CHT560, Lot Number 2018091190;  CHT560, Lot Number 2020032490;  CHT560, Lot Number 2020051990;  CHT560, Lot Number 2020062490;  CHT560, Lot Number 2020070190;  CHT560, Lot Number 2020071490;  CHT560, Lot Number 2020121590;  CHT560, Lot Number 2021042690;  CHT560, Lot Number 2021082390;  CHT560, Lot Number 2021091490;  CHT560, Lot Number 2022022490;  CHT560, Lot Number 2022050490;  CIT7050C, Lot Number 2023081480;  CIT7050C, Lot Number 2023101680;  CIT7050C, Lot Number 2024010590;  DYNJ05162, Lot Number 2020082050;  ECVC7860, Lot Number 2023101990;  CHT1570A, Lot Number 2021051290;  MNS12150, Lot Number 2019082790;  MNS12150, Lot Number 2020021290;  MNS12150, Lot Number 2020060290;  MNS12150, Lot Number 2020101390;  MNS12150, Lot Number 2020111790;  MNS12150, Lot Number 2020121890;  MNS12150, Lot Number 2021051290;  MNS12150, Lot Number 2021071390;  MNS12150, Lot Number 2022012890;  MNS12150, Lot Number 2022061790;  MNS12150, Lot Number 2022092290;  MNS12150, Lot Number 2023010690;  MNS12150, Lot Number 2023030690;  MNS12150, Lot Number 2023082490;  DYNDH1297, Lot Number 2019091750;  DYNDH1406, Lot Number 2023102790;  PT215, Lot Number 2018050350;  PT215, Lot Number 2018100950;  PT215, Lot Number 2018102950;  PT215, Lot Number 2019091750;  PT215, Lot Number 2019100450;  PT215, Lot Number 2020051850;  PT215, Lot Number 2020082050;  PT215, Lot Number 2020102850;  PT215, Lot Number 2020121550;  PT215, Lot Number 2021021850;  PT215, Lot Number 2021111850;  PT215, Lot Number 2022021650;  PT215, Lot Number 2022043050;  PT215, Lot Number 2022072990;  PT215, Lot Number 2023012390;  PT215, Lot Number 2023032790;  PT215, Lot Number 2023102790;  PT215, Lot Number 2023122090;  SPEC0197B, Lot Number 2018102950;  CVI4575, Lot Number 2023102590;  CVI4575, Lot Number 2023120190;  MNS10875A, Lot Number 2021060190;  DT8525, Lot Number 2023070590;  DT8525, Lot Number 2023092890;  DT8525, Lot Number 2024022090;  IVS3320, Lot Number 2021061490;  DYNDH1910, Lot Number 2023120480;  MNS3560, Lot Number 2021091490;  DYNDC2945, Lot Number 2023062190;  EBSI1241, Lot Number 2021051290;  MNS11590, Lot Number 2019072590;  MNS11590, Lot Number 2021010690;  MNS11590, Lot Number 2021061490;  MNS11590, Lot Number 2021122190;  MNS11590, Lot Number 2022050490;  MNS11590, Lot Number 2023032390;  MNS11590, Lot Number 2023062190;  MNS11590, Lot Number 2023101990;  DYNDC2859A, Lot Number 2021082390;  MNS5785, Lot Number 2023032290;  MNS5785, Lot Number 2023090590;  MNS5785, Lot Number 2023120790;  MNS5785, Lot Number 2024030690;  SUT4020, Lot Number 2020051990;  SUT4020, Lot Number 2020062490;  UVT125, Lot Number 2021082390;  MNS5460, Lot Number 2020051990;  UVT1080, Lot Number 2022121990;  UVT1080, Lot Number 2023090590;  UVT1100A, Lot Number 2022050280;  UVT1100A, Lot Number 2023011680;  UVT1100A, Lot Number 2023041780;  UVT1100A, Lot Number 2023061980;  UVT1100A, Lot Number 2023101680;  UVT1100A, Lot Number 2023120480;  UVT1100A, Lot Number 2024011580;  MNS11020A, Lot Number 2021060190. 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-2767-2024&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-2767-2024&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-2767-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2767-2024 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.",
      "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-2767-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2767-2024&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-2767-2024/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-2767-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2767-2024",
            "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 II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "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": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-04-08",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "ART245C, Lot Number 2023101990;  ART1170, Lot Number 2022121990;  ART1170, Lot Number 2023012790;  ART1170, Lot Number 2023021590;  PT220, Lot Number 2021061490;  PT220, Lot Number 2022011090;  MNS12670A, Lot Number 2021060190;  MNS12670A, Lot Number 2022011090;  MNS12670A, Lot Number 2023022190;  MNS12670A, Lot Number 2023101890;  SUT20455, Lot Number 2021060190;  SUT20455, Lot Number 2022011090;  SUT20455, Lot Number 2023012390;  BT1060, Lot Number 2020062490;  BT1015, Lot Number 2021060190;  DYNDH1137C, Lot Number 2021091490;  DYNDH1137C, Lot Number 2022121990;  SPEC4380, Lot Number 2018102950;  SPEC4380, Lot Number 2023032390;  DYNJTS0214, Lot Number 2022061790;  DYNJTS0214, Lot Number 22121990;  SPEC0130C, Lot Number 2023022190;  S5078BF09, Lot Number 2020051850;  S5078BF09, Lot Number 2022092290;  CHT560, Lot Number 2018042790;  CHT560, Lot Number 2018050790;  CHT560, Lot Number 2018060490;  CHT560, Lot Number 2018080790;  CHT560, Lot Number 2018091190;  CHT560, Lot Number 2020032490;  CHT560, Lot Number 2020051990;  CHT560, Lot Number 2020062490;  CHT560, Lot Number 2020070190;  CHT560, Lot Number 2020071490;  CHT560, Lot Number 2020121590;  CHT560, Lot Number 2021042690;  CHT560, Lot Number 2021082390;  CHT560, Lot Number 2021091490;  CHT560, Lot Number 2022022490;  CHT560, Lot Number 2022050490;  CIT7050C, Lot Number 2023081480;  CIT7050C, Lot Number 2023101680;  CIT7050C, Lot Number 2024010590;  DYNJ05162, Lot Number 2020082050;  ECVC7860, Lot Number 2023101990;  CHT1570A, Lot Number 2021051290;  MNS12150, Lot Number 2019082790;  MNS12150, Lot Number 2020021290;  MNS12150, Lot Number 2020060290;  MNS12150, Lot Number 2020101390;  MNS12150, Lot Number 2020111790;  MNS12150, Lot Number 2020121890;  MNS12150, Lot Number 2021051290;  MNS12150, Lot Number 2021071390;  MNS12150, Lot Number 2022012890;  MNS12150, Lot Number 2022061790;  MNS12150, Lot Number 2022092290;  MNS12150, Lot Number 2023010690;  MNS12150, Lot Number 2023030690;  MNS12150, Lot Number 2023082490;  DYNDH1297, Lot Number 2019091750;  DYNDH1406, Lot Number 2023102790;  PT215, Lot Number 2018050350;  PT215, Lot Number 2018100950;  PT215, Lot Number 2018102950;  PT215, Lot Number 2019091750;  PT215, Lot Number 2019100450;  PT215, Lot Number 2020051850;  PT215, Lot Number 2020082050;  PT215, Lot Number 2020102850;  PT215, Lot Number 2020121550;  PT215, Lot Number 2021021850;  PT215, Lot Number 2021111850;  PT215, Lot Number 2022021650;  PT215, Lot Number 2022043050;  PT215, Lot Number 2022072990;  PT215, Lot Number 2023012390;  PT215, Lot Number 2023032790;  PT215, Lot Number 2023102790;  PT215, Lot Number 2023122090;  SPEC0197B, Lot Number 2018102950;  CVI4575, Lot Number 2023102590;  CVI4575, Lot Number 2023120190;  MNS10875A, Lot Number 2021060190;  DT8525, Lot Number 2023070590;  DT8525, Lot Number 2023092890;  DT8525, Lot Number 2024022090;  IVS3320, Lot Number 2021061490;  DYNDH1910, Lot Number 2023120480;  MNS3560, Lot Number 2021091490;  DYNDC2945, Lot Number 2023062190;  EBSI1241, Lot Number 2021051290;  MNS11590, Lot Number 2019072590;  MNS11590, Lot Number 2021010690;  MNS11590, Lot Number 2021061490;  MNS11590, Lot Number 2021122190;  MNS11590, Lot Number 2022050490;  MNS11590, Lot Number 2023032390;  MNS11590, Lot Number 2023062190;  MNS11590, Lot Number 2023101990;  DYNDC2859A, Lot Number 2021082390;  MNS5785, Lot Number 2023032290;  MNS5785, Lot Number 2023090590;  MNS5785, Lot Number 2023120790;  MNS5785, Lot Number 2024030690;  SUT4020, Lot Number 2020051990;  SUT4020, Lot Number 2020062490;  UVT125, Lot Number 2021082390;  MNS5460, Lot Number 2020051990;  UVT1080, Lot Number 2022121990;  UVT1080, Lot Number 2023090590;  UVT1100A, Lot Number 2022050280;  UVT1100A, Lot Number 2023011680;  UVT1100A, Lot Number 2023041780;  UVT1100A, Lot Number 2023061980;  UVT1100A, Lot Number 2023101680;  UVT1100A, Lot Number 2023120480;  UVT1100A, Lot Number 2024011580;  MNS11020A, Lot Number 2021060190",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}