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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2772-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Centurion procedure kits, labeled as:    1) ARTHROGRAM TRAY, Pack Number DYNDH1349;   2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) BIOPSY KIT, Pack Number DYNDH1570;   5) BIOPSY TRAY-LF, Pack Number SPEC4380;   6) BMA BX TRAY, Pack Number DYNDH1050A;   7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   8) CATHETER ON/OFF KIT, Pack Number DT5490B;   9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   11) CIRCUMCISION TRAY, Pack Number CIT6260;   12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;   13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   14) DELIVERY PACK, Pack Number MNS2925A;   15) DELIVERY PACK, Pack Number MNS2925B;   16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;   17) FINE LACERATION KIT, Pack Number SUT19360;   18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;   19) GENERAL UTILITY, Pack Number DYNDA2524;   20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;   22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   23) LACERATION TRAY, Pack Number DYNDL1757;   24) MYELOGRAM TRAY, Pack Number DYNDH1531;   25) OB DELIVERY SET, Pack Number MNS3355;   26) OB DELIVERY TRAY, Pack Number MNS10875;   27) OB DELIVERY TRAY, Pack Number MNS5575;   28) OB DELIVERY TRAY, Pack Number MNS10875A;   29) PICU LINE TRAY, Pack Number DYNDC1960A;   30) PORT ACCESS KIT, Pack Number DYNDC2945;   31) PORT ACCESS TRAY, Pack Number EBSI1241;   32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;   33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   34) SUTURING SET, Pack Number SUT9790;   35) SUTURING SET, Pack Number SUT4020;   36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;   37) U.A.C. TRAY, Pack Number UVT125;   38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;   40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
  "description": "FDA recall Z-2772-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits, labeled as:    1) ARTHROGRAM TRAY, Pack Number DYNDH1349;   2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) BIOPSY KIT, Pack Number DYNDH1570;   5) BIOPSY TRAY-LF, Pack Number SPEC4380;   6) BMA BX TRAY, Pack Number DYNDH1050A;   7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   8) CATHETER ON/OFF KIT, Pack Number DT5490B;   9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   11) CIRCUMCISION TRAY, Pack Number CIT6260;   12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;   13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   14) DELIVERY PACK, Pack Number MNS2925A;   15) DELIVERY PACK, Pack Number MNS2925B;   16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;   17) FINE LACERATION KIT, Pack Number SUT19360;   18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;   19) GENERAL UTILITY, Pack Number DYNDA2524;   20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;   22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   23) LACERATION TRAY, Pack Number DYNDL1757;   24) MYELOGRAM TRAY, Pack Number DYNDH1531;   25) OB DELIVERY SET, Pack Number MNS3355;   26) OB DELIVERY TRAY, Pack Number MNS10875;   27) OB DELIVERY TRAY, Pack Number MNS5575;   28) OB DELIVERY TRAY, Pack Number MNS10875A;   29) PICU LINE TRAY, Pack Number DYNDC1960A;   30) PORT ACCESS KIT, Pack Number DYNDC2945;   31) PORT ACCESS TRAY, Pack Number EBSI1241;   32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;   33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   34) SUTURING SET, Pack Number SUT9790;   35) SUTURING SET, Pack Number SUT4020;   36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;   37) U.A.C. TRAY, Pack Number UVT125;   38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;   40) 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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2772-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Centurion procedure kits, labeled as:    1) ARTHROGRAM TRAY, Pack Number DYNDH1349;   2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) BIOPSY KIT, Pack Number DYNDH1570;   5) BIOPSY TRAY-LF, Pack Number SPEC4380;   6) BMA BX TRAY, Pack Number DYNDH1050A;   7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   8) CATHETER ON/OFF KIT, Pack Number DT5490B;   9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   11) CIRCUMCISION TRAY, Pack Number CIT6260;   12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;   13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   14) DELIVERY PACK, Pack Number MNS2925A;   15) DELIVERY PACK, Pack Number MNS2925B;   16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;   17) FINE LACERATION KIT, Pack Number SUT19360;   18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;   19) GENERAL UTILITY, Pack Number DYNDA2524;   20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;   22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   23) LACERATION TRAY, Pack Number DYNDL1757;   24) MYELOGRAM TRAY, Pack Number DYNDH1531;   25) OB DELIVERY SET, Pack Number MNS3355;   26) OB DELIVERY TRAY, Pack Number MNS10875;   27) OB DELIVERY TRAY, Pack Number MNS5575;   28) OB DELIVERY TRAY, Pack Number MNS10875A;   29) PICU LINE TRAY, Pack Number DYNDC1960A;   30) PORT ACCESS KIT, Pack Number DYNDC2945;   31) PORT ACCESS TRAY, Pack Number EBSI1241;   32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;   33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   34) SUTURING SET, Pack Number SUT9790;   35) SUTURING SET, Pack Number SUT4020;   36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;   37) U.A.C. TRAY, Pack Number UVT125;   38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;   40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2772-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2772-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Centurion procedure kits, labeled as:    1) ARTHROGRAM TRAY, Pack Number DYNDH1349;   2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) BIOPSY KIT, Pack Number DYNDH1570;   5) BIOPSY TRAY-LF, Pack Number SPEC4380;   6) BMA BX TRAY, Pack Number DYNDH1050A;   7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   8) CATHETER ON/OFF KIT, Pack Number DT5490B;   9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   11) CIRCUMCISION TRAY, Pack Number CIT6260;   12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;   13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   14) DELIVERY PACK, Pack Number MNS2925A;   15) DELIVERY PACK, Pack Number MNS2925B;   16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;   17) FINE LACERATION KIT, Pack Number SUT19360;   18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;   19) GENERAL UTILITY, Pack Number DYNDA2524;   20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;   22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   23) LACERATION TRAY, Pack Number DYNDL1757;   24) MYELOGRAM TRAY, Pack Number DYNDH1531;   25) OB DELIVERY SET, Pack Number MNS3355;   26) OB DELIVERY TRAY, Pack Number MNS10875;   27) OB DELIVERY TRAY, Pack Number MNS5575;   28) OB DELIVERY TRAY, Pack Number MNS10875A;   29) PICU LINE TRAY, Pack Number DYNDC1960A;   30) PORT ACCESS KIT, Pack Number DYNDC2945;   31) PORT ACCESS TRAY, Pack Number EBSI1241;   32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;   33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   34) SUTURING SET, Pack Number SUT9790;   35) SUTURING SET, Pack Number SUT4020;   36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;   37) U.A.C. TRAY, Pack Number UVT125;   38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;   40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A",
      "text": "The FDA logged enforcement record Z-2772-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Centurion procedure kits, labeled as:    1) ARTHROGRAM TRAY, Pack Number DYNDH1349;   2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;   3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220;   4) BIOPSY KIT, Pack Number DYNDH1570;   5) BIOPSY TRAY-LF, Pack Number SPEC4380;   6) BMA BX TRAY, Pack Number DYNDH1050A;   7) BREAST BIOPSY TRAY, Pack Number SPEC0130C;   8) CATHETER ON/OFF KIT, Pack Number DT5490B;   9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09;   10) CHEST TUBE INSERTION TRAY, Pack Number CHT705;   11) CIRCUMCISION TRAY, Pack Number CIT6260;   12) CUSTOM BIOPSY TRAY, Pack Number MNS4815;   13) DELIVERY ACCESSORY KIT, Pack Number MNS6496;   14) DELIVERY PACK, Pack Number MNS2925A;   15) DELIVERY PACK, Pack Number MNS2925B;   16) E. R. LACERATION TRAY, Pack Number DYNDL1187A;   17) FINE LACERATION KIT, Pack Number SUT19360;   18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B;   19) GENERAL UTILITY, Pack Number DYNDA2524;   20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A;   21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B;   22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;   23) LACERATION TRAY, Pack Number DYNDL1757;   24) MYELOGRAM TRAY, Pack Number DYNDH1531;   25) OB DELIVERY SET, Pack Number MNS3355;   26) OB DELIVERY TRAY, Pack Number MNS10875;   27) OB DELIVERY TRAY, Pack Number MNS5575;   28) OB DELIVERY TRAY, Pack Number MNS10875A;   29) PICU LINE TRAY, Pack Number DYNDC1960A;   30) PORT ACCESS KIT, Pack Number DYNDC2945;   31) PORT ACCESS TRAY, Pack Number EBSI1241;   32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A;   33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A;   34) SUTURING SET, Pack Number SUT9790;   35) SUTURING SET, Pack Number SUT4020;   36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A;   37) U.A.C. TRAY, Pack Number UVT125;   38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;   39) VAGINAL DELIVERY TRAY, Pack Number MNS11020;   40) 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: DYNDH1349, Lot Number 2019061090;  SPEC0400, Lot Number 2022010790;  SPEC0400, Lot Number 2022061490;  PT220, Lot Number 2020090390;  DYNDH1570, Lot Number 2023091390;  SPEC4380, Lot Number 2023110890;  DYNDH1050A, Lot Number 2019100490;  SPEC0130C, Lot Number 2020072090;  DT5490B, Lot Number 2022091590;  S5078BF09, Lot Number 2022122390;  CHT705, Lot Number 2021072990;  CIT6260, Lot Number 2022031190;  MNS4815, Lot Number 2022042890;  MNS6496, Lot Number 2018112690;  MNS6496, Lot Number 2019061390;  MNS6496, Lot Number 2020040190;  MNS6496, Lot Number 2020062290;  MNS6496, Lot Number 2020090290;  MNS6496, Lot Number 2021072990;  MNS6496, Lot Number 2022010790;  MNS6496, Lot Number 2022080890;  MNS6496, Lot Number 2022122390;  MNS6496, Lot Number 2023040690;  MNS2925A, Lot Number 2019080690;  MNS2925A, Lot Number 2019101190;  MNS2925B, Lot Number 2020032090;  MNS2925B, Lot Number 2020071690;  DYNDL1187A, Lot Number 2019080590;  DYNDL1187A, Lot Number 2019100490;  SUT19360, Lot Number 2023021090;  SPEC0248B, Lot Number 2019041790;  DYNDA2524, Lot Number 2019100490;  DYNDH1227A, Lot Number 2019061090;  DYNDH1227B, Lot Number 2019100490;  MNS12150, Lot Number 2021072990;  MNS12150, Lot Number 2022031190;  DYNDL1757, Lot Number 2019061090;  DYNDH1531, Lot Number 2023021090;  MNS3355, Lot Number 2019080590;  MNS3355, Lot Number 2019100490;  MNS3355, Lot Number 2020050890;  MNS3355, Lot Number 2020091090;  MNS3355, Lot Number 2020113090;  MNS3355, Lot Number 2021030890;  MNS3355, Lot Number 2021040990;  MNS3355, Lot Number 2021052890;  MNS3355, Lot Number 2021071590;  MNS3355, Lot Number 2021080990;  MNS3355, Lot Number 2021122390;  MNS3355, Lot Number 2022030790;  MNS3355, Lot Number 2022071590;  MNS3355, Lot Number 2022080590;  MNS3355, Lot Number 2022101490;  MNS3355, Lot Number 2023021090;  MNS3355, Lot Number 2023053090;  MNS3355, Lot Number 2023091390;  MNS3355, Lot Number 2023121490;  MNS10875, Lot Number 2019031590;  MNS5575, Lot Number 2019061090;  MNS5575, Lot Number 2020072090;  MNS5575, Lot Number 2020081790;  MNS10875A, Lot Number 2020081790;  MNS10875A, Lot Number 2020090390;  MNS5575, Lot Number 2020102390;  MNS5575, Lot Number 2021012590;  MNS10875A, Lot Number 2021012690;  MNS10875A, Lot Number 2021031190;  MNS10875A, Lot Number 2021051490;  MNS10875A, Lot Number 2021072990;  MNS10875A, Lot Number 2021102890;  MNS10875A, Lot Number 2022031190;  MNS10875A, Lot Number 2022061490;  MNS10875A, Lot Number 2022091590;  MNS10875A, Lot Number 2023040690;  MNS10875A, Lot Number 2023092990;  MNS10875A, Lot Number 2023110890;  DYNDC1960A, Lot Number 2022010790;  DYNDC2945, Lot Number 2023040690;  EBSI1241, Lot Number 2021021190;  SPEC0156A, Lot Number 2019100490;  DYNDC2859A, Lot Number 2020081790;  DYNDC2859A, Lot Number 2023053090;  SUT9790, Lot Number 2020090390;  SUT9790, Lot Number 2020113090;  SUT4020, Lot Number 2021051490;  SUT4020, Lot Number 2021072990;  SUT4020, Lot Number 2022071590;  DYNDL1422A, Lot Number 2019061090;  UVT125, Lot Number 2023110890;  MNS9580, Lot Number 2019100490;  MNS9580, Lot Number 2022042890;  MNS11020, Lot Number 2018103190;  MNS11020, Lot Number 2019012390;  MNS11020, Lot Number 2019041790;  MNS11020A, Lot Number 2019080690;  MNS11020A, Lot Number 2021021190;  MNS11020A, Lot Number 2021030390;  MNS11020A, Lot Number 2021041690;  MNS11020A, Lot Number 2022042890. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-2772-2024&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-2772-2024&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-2772-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2772-2024 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-2772-2024&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-2772-2024&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-2772-2024/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."
    }
  ],
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      "name": "FDA recall details — Z-2772-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2772-2024",
            "Status": "recorded"
          }
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          "@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": "DYNDH1349, Lot Number 2019061090;  SPEC0400, Lot Number 2022010790;  SPEC0400, Lot Number 2022061490;  PT220, Lot Number 2020090390;  DYNDH1570, Lot Number 2023091390;  SPEC4380, Lot Number 2023110890;  DYNDH1050A, Lot Number 2019100490;  SPEC0130C, Lot Number 2020072090;  DT5490B, Lot Number 2022091590;  S5078BF09, Lot Number 2022122390;  CHT705, Lot Number 2021072990;  CIT6260, Lot Number 2022031190;  MNS4815, Lot Number 2022042890;  MNS6496, Lot Number 2018112690;  MNS6496, Lot Number 2019061390;  MNS6496, Lot Number 2020040190;  MNS6496, Lot Number 2020062290;  MNS6496, Lot Number 2020090290;  MNS6496, Lot Number 2021072990;  MNS6496, Lot Number 2022010790;  MNS6496, Lot Number 2022080890;  MNS6496, Lot Number 2022122390;  MNS6496, Lot Number 2023040690;  MNS2925A, Lot Number 2019080690;  MNS2925A, Lot Number 2019101190;  MNS2925B, Lot Number 2020032090;  MNS2925B, Lot Number 2020071690;  DYNDL1187A, Lot Number 2019080590;  DYNDL1187A, Lot Number 2019100490;  SUT19360, Lot Number 2023021090;  SPEC0248B, Lot Number 2019041790;  DYNDA2524, Lot Number 2019100490;  DYNDH1227A, Lot Number 2019061090;  DYNDH1227B, Lot Number 2019100490;  MNS12150, Lot Number 2021072990;  MNS12150, Lot Number 2022031190;  DYNDL1757, Lot Number 2019061090;  DYNDH1531, Lot Number 2023021090;  MNS3355, Lot Number 2019080590;  MNS3355, Lot Number 2019100490;  MNS3355, Lot Number 2020050890;  MNS3355, Lot Number 2020091090;  MNS3355, Lot Number 2020113090;  MNS3355, Lot Number 2021030890;  MNS3355, Lot Number 2021040990;  MNS3355, Lot Number 2021052890;  MNS3355, Lot Number 2021071590;  MNS3355, Lot Number 2021080990;  MNS3355, Lot Number 2021122390;  MNS3355, Lot Number 2022030790;  MNS3355, Lot Number 2022071590;  MNS3355, Lot Number 2022080590;  MNS3355, Lot Number 2022101490;  MNS3355, Lot Number 2023021090;  MNS3355, Lot Number 2023053090;  MNS3355, Lot Number 2023091390;  MNS3355, Lot Number 2023121490;  MNS10875, Lot Number 2019031590;  MNS5575, Lot Number 2019061090;  MNS5575, Lot Number 2020072090;  MNS5575, Lot Number 2020081790;  MNS10875A, Lot Number 2020081790;  MNS10875A, Lot Number 2020090390;  MNS5575, Lot Number 2020102390;  MNS5575, Lot Number 2021012590;  MNS10875A, Lot Number 2021012690;  MNS10875A, Lot Number 2021031190;  MNS10875A, Lot Number 2021051490;  MNS10875A, Lot Number 2021072990;  MNS10875A, Lot Number 2021102890;  MNS10875A, Lot Number 2022031190;  MNS10875A, Lot Number 2022061490;  MNS10875A, Lot Number 2022091590;  MNS10875A, Lot Number 2023040690;  MNS10875A, Lot Number 2023092990;  MNS10875A, Lot Number 2023110890;  DYNDC1960A, Lot Number 2022010790;  DYNDC2945, Lot Number 2023040690;  EBSI1241, Lot Number 2021021190;  SPEC0156A, Lot Number 2019100490;  DYNDC2859A, Lot Number 2020081790;  DYNDC2859A, Lot Number 2023053090;  SUT9790, Lot Number 2020090390;  SUT9790, Lot Number 2020113090;  SUT4020, Lot Number 2021051490;  SUT4020, Lot Number 2021072990;  SUT4020, Lot Number 2022071590;  DYNDL1422A, Lot Number 2019061090;  UVT125, Lot Number 2023110890;  MNS9580, Lot Number 2019100490;  MNS9580, Lot Number 2022042890;  MNS11020, Lot Number 2018103190;  MNS11020, Lot Number 2019012390;  MNS11020, Lot Number 2019041790;  MNS11020A, Lot Number 2019080690;  MNS11020A, Lot Number 2021021190;  MNS11020A, Lot Number 2021030390;  MNS11020A, Lot Number 2021041690;  MNS11020A, Lot Number 2022042890",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "worldwide",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}