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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2990-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience kits labeled as:    1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;   2) KIT LEFT HEART-VA MED, Pack Number 132701;   3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;   4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;   5) KIT ANGIO CSTM-SETON, Pack Number 143267;   6) SYR- VA HOSPITAL, Pack Number 144684;   7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;   8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;   9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;   10) CSTM MANIFOLD KIT , Pack Number VASC1130",
  "description": "FDA recall Z-2990-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;   2) KIT LEFT HEART-VA MED, Pack Number 132701;   3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;   4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;   5) KIT ANGIO CSTM-SETON, Pack Number 143267;   6) SYR- VA HOSPITAL, Pack Number 144684;   7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;   8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;   9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;   10) CSTM MANIFOLD KIT , Pack Number VASC1130 (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",
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    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2990-2024&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience kits labeled as:    1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;   2) KIT LEFT HEART-VA MED, Pack Number 132701;   3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;   4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;   5) KIT ANGIO CSTM-SETON, Pack Number 143267;   6) SYR- VA HOSPITAL, Pack Number 144684;   7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;   8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;   9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;   10) CSTM MANIFOLD KIT , Pack Number VASC1130",
    "manufacturer": {
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2990-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2990-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as:    1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;   2) KIT LEFT HEART-VA MED, Pack Number 132701;   3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;   4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;   5) KIT ANGIO CSTM-SETON, Pack Number 143267;   6) SYR- VA HOSPITAL, Pack Number 144684;   7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;   8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;   9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;   10) CSTM MANIFOLD KIT , Pack Number VASC1130",
      "text": "The FDA logged enforcement record Z-2990-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as:    1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ;   2) KIT LEFT HEART-VA MED, Pack Number 132701;   3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ;   4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ;   5) KIT ANGIO CSTM-SETON, Pack Number 143267;   6) SYR- VA HOSPITAL, Pack Number 144684;   7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A;   8) CSTM MANIFOLD KIT , Pack Number SAMPC0547;   9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ;   10) CSTM MANIFOLD KIT , Pack Number VASC1130 — 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: 129736 , Lot Number 20DKA054 ;  132701, Lot Number 24ADB481;  132701, Lot Number 24ADA120;  132701, Lot Number 23GDC081;  132701, Lot Number 23DDC268;  132701, Lot Number 23CDC677;  132701, Lot Number 22LDA569;  132701, Lot Number 22IDC180;  132701, Lot Number 22IDA238;  132701, Lot Number 22DDB501;  132701, Lot Number 22DDA530;  132701, Lot Number 22ADB638;  132701, Lot Number 21KDB209;  132701, Lot Number 21KDA233;  132701, Lot Number 21JDA611;  132701, Lot Number 21FDC090;  132701, Lot Number 21EDB524;  132701, Lot Number 21CDB488;  132701, Lot Number 20LDB085;  132701, Lot Number 20KDA727;  132701, Lot Number 20FDC203;  132701, Lot Number 20BDB590;  132701, Lot Number 20BDA433;  134085 , Lot Number 22BBZ656Z;  142643 , Lot Number 22NBF339Z;  143267, Lot Number 22GMA268;  144684, Lot Number 24AMB389;  144684, Lot Number 23LMG949;  144684, Lot Number 23KMJ307;  144684, Lot Number 23HMI452;  144684, Lot Number 23GMB839;  144684, Lot Number 23FMI280;  144684, Lot Number 23DMH268;  144684, Lot Number 23CMH563;  144684, Lot Number 23BMF752;  144684, Lot Number 22LMA051;  144684, Lot Number 22IMA306;  CDS985003A, Lot Number 24CMC421;  CDS985003A, Lot Number 24CMC421;  CDS985003A , Lot Number 21GBM644 ;  CDS985003A , Lot Number 19BBN133 ;  CDS985003A , Lot Number 19CBQ620 ;  CDS985003A , Lot Number 19EBW590 ;  CDS985003A , Lot Number 19GBB647 ;  CDS985003A , Lot Number 19LBU108 ;  CDS985003A , Lot Number 20ABT969 ;  CDS985003A , Lot Number 20ABW952 ;  CDS985003A , Lot Number 20DBD342 ;  CDS985003A , Lot Number 20EBS254 ;  CDS985003A , Lot Number 20GBJ904 ;  CDS985003A , Lot Number 20IBG340 ;  CDS985003A , Lot Number 20JBP424 ;  CDS985003A , Lot Number 20KBU982 ;  CDS985003A , Lot Number 21CBW933 ;  CDS985003A , Lot Number 21EBE602 ;  CDS985003A , Lot Number 22CMA036 ;  CDS985003A , Lot Number 22DMI553 ;  CDS985003A , Lot Number 23DMH255 ;  CDS985003A , Lot Number 23DMH760 ;  CDS985003A , Lot Number 23FMF204 ;  CDS985003A , Lot Number 23GMB004 ;  CDS985003A , Lot Number 23GMI569 ;  CDS985003A , Lot Number 23JMJ652 ;  CDS985003A , Lot Number 24AMB671 ;  SAMPC0547, Lot Number 19BDB826 ;  VASC1074 , Lot Number 22BBR869 ;  VASC1130 , Lot Number 20LME799. 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-2990-2024&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-2990-2024&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-2990-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2990-2024 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-2990-2024&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-2990-2024&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-2990-2024/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": {
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        "supported": true,
        "adjudged": false,
        "operative": true
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      "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-2990-2024",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2990-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
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          "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"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "129736 , Lot Number 20DKA054 ;  132701, Lot Number 24ADB481;  132701, Lot Number 24ADA120;  132701, Lot Number 23GDC081;  132701, Lot Number 23DDC268;  132701, Lot Number 23CDC677;  132701, Lot Number 22LDA569;  132701, Lot Number 22IDC180;  132701, Lot Number 22IDA238;  132701, Lot Number 22DDB501;  132701, Lot Number 22DDA530;  132701, Lot Number 22ADB638;  132701, Lot Number 21KDB209;  132701, Lot Number 21KDA233;  132701, Lot Number 21JDA611;  132701, Lot Number 21FDC090;  132701, Lot Number 21EDB524;  132701, Lot Number 21CDB488;  132701, Lot Number 20LDB085;  132701, Lot Number 20KDA727;  132701, Lot Number 20FDC203;  132701, Lot Number 20BDB590;  132701, Lot Number 20BDA433;  134085 , Lot Number 22BBZ656Z;  142643 , Lot Number 22NBF339Z;  143267, Lot Number 22GMA268;  144684, Lot Number 24AMB389;  144684, Lot Number 23LMG949;  144684, Lot Number 23KMJ307;  144684, Lot Number 23HMI452;  144684, Lot Number 23GMB839;  144684, Lot Number 23FMI280;  144684, Lot Number 23DMH268;  144684, Lot Number 23CMH563;  144684, Lot Number 23BMF752;  144684, Lot Number 22LMA051;  144684, Lot Number 22IMA306;  CDS985003A, Lot Number 24CMC421;  CDS985003A, Lot Number 24CMC421;  CDS985003A , Lot Number 21GBM644 ;  CDS985003A , Lot Number 19BBN133 ;  CDS985003A , Lot Number 19CBQ620 ;  CDS985003A , Lot Number 19EBW590 ;  CDS985003A , Lot Number 19GBB647 ;  CDS985003A , Lot Number 19LBU108 ;  CDS985003A , Lot Number 20ABT969 ;  CDS985003A , Lot Number 20ABW952 ;  CDS985003A , Lot Number 20DBD342 ;  CDS985003A , Lot Number 20EBS254 ;  CDS985003A , Lot Number 20GBJ904 ;  CDS985003A , Lot Number 20IBG340 ;  CDS985003A , Lot Number 20JBP424 ;  CDS985003A , Lot Number 20KBU982 ;  CDS985003A , Lot Number 21CBW933 ;  CDS985003A , Lot Number 21EBE602 ;  CDS985003A , Lot Number 22CMA036 ;  CDS985003A , Lot Number 22DMI553 ;  CDS985003A , Lot Number 23DMH255 ;  CDS985003A , Lot Number 23DMH760 ;  CDS985003A , Lot Number 23FMF204 ;  CDS985003A , Lot Number 23GMB004 ;  CDS985003A , Lot Number 23GMI569 ;  CDS985003A , Lot Number 23JMJ652 ;  CDS985003A , Lot Number 24AMB671 ;  SAMPC0547, Lot Number 19BDB826 ;  VASC1074 , Lot Number 22BBR869 ;  VASC1130 , Lot Number 20LME799",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}