{
  "@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-2134-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Stimuplex A, 30 DEG, 22GX2\", 0.70x50mm, Catalogue Number: 4894502",
  "description": "FDA recall Z-2134-2024 — B Braun Medical Inc is recalling Stimuplex A, 30 DEG, 22GX2\", 0.70x50mm, Catalogue Number: 4894502 (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-2134-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Stimuplex A, 30 DEG, 22GX2\", 0.70x50mm, Catalogue Number: 4894502",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "B Braun Medical Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2134-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2134-2024: B Braun Medical Inc is recalling Stimuplex A, 30 DEG, 22GX2\", 0.70x50mm, Catalogue Number: 4894502",
      "text": "The FDA logged enforcement record Z-2134-2024: B Braun Medical Inc is voluntarily recalling Stimuplex A, 30 DEG, 22GX2\", 0.70x50mm, Catalogue Number: 4894502 — reason: The devices are labeled \"not made with DEHP\" or the DEHP free symbol; however, the glue used contains traces of DEHP.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-17. Affected lots/codes: Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 20E19, 20E20, 19E21, 19E22, 20E22, 23E26, 20E27, 23E31, 19F12, 19F13, 19F15, 19G03, 19G04, 19G06, 19G09, 19G20, 19G21, 19G24, 19G25, 19G27, 19H23, 19H28, 19H30, 19I11, 19I21, 19I25, 19I26, 19K11, 19K16, 19K17, 19K24, 19K25, 19L12, 19L13, 19L15, 19L19, 19M12, 19M14, 19M17, 19M21, 19M24, 19M26, 20A30, 20A31, 20B15, 20B18, 20B19, 20B21, 20B26, 20B27, 20C14, 20C17, 20C18, 20D01, 20D02, 20D04, 20D14, 20D16, 20D17, 20D21, 20D29, 20F06, 20F10, 20F11, 20F12, 20F13, 20G21, 20G22, 20G23, 20G29, 20G31, 20H01, 20H05, 20H26, 20H27, 20H29, 20L27, 20L28, 20M03, 20M19, 20M23, 20M25, 20M26, 21A16, 21A19, 21B04, 21B06, 21B10, 21B18, 21B20, 21B25, 21C11, 21C13, 21C17, 21D07, 21D08, 21D10, 21D29, 21F19, 21F23, 21F24, 21F25, 21F26, 21F30, 21G08, 21G09, 21G10, 21G14, 21G17, 21G20, 21G21, 21H05, 21H06, 21H07, 21H26, 21H28, 21I04, 21I22, 21I26, 21K07, 21K09, 21K13, 21K29, 21K30, 21L16, 21L17, 21L18, 21L19, 21L20, 21L30, 21M02, 21M03, 21M11, 21M14, 22A08, 22A25, 22B25, 22B27, 22C02, 22C03, 22C25, 22C29, 22D14, 22D15, 22D19, 22D21, 22F02, 22F04, 22G14, 22G16, 22G21, 22G23, 22G29, 22H25, 22I01, 22I03, 22I08, 22I28, 22K01, 22K05, 22K16, 22K18, 22K19, 22K20, 22L01, 22L02, 22L15, 22L16, 22M06, 22M15, 22M17, 23A08, 23A11, 23A31, 23B01, 23B07, 23B25, 23B28, 23C16, 23C18, 23C21, 23D19, 23D22, 23D28, 23F07, 23F30, 23G07, 23G11, 23G29, 23H01, 23I05, 23I06, 23I07, 23I23, 23I26, 23I28, 23I29, 23K18, 23K19,. 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-2134-2024&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-2134-2024&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-2134-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2134-2024 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-2134-2024&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-2134-2024&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-2134-2024/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-2134-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2134-2024",
            "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": "B Braun Medical Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The devices are labeled \"not made with DEHP\" or the DEHP free symbol; however, the glue used contains traces of DEHP.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-05-17",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 20E19, 20E20, 19E21, 19E22, 20E22, 23E26, 20E27, 23E31, 19F12, 19F13, 19F15, 19G03, 19G04, 19G06, 19G09, 19G20, 19G21, 19G24, 19G25, 19G27, 19H23, 19H28, 19H30, 19I11, 19I21, 19I25, 19I26, 19K11, 19K16, 19K17, 19K24, 19K25, 19L12, 19L13, 19L15, 19L19, 19M12, 19M14, 19M17, 19M21, 19M24, 19M26, 20A30, 20A31, 20B15, 20B18, 20B19, 20B21, 20B26, 20B27, 20C14, 20C17, 20C18, 20D01, 20D02, 20D04, 20D14, 20D16, 20D17, 20D21, 20D29, 20F06, 20F10, 20F11, 20F12, 20F13, 20G21, 20G22, 20G23, 20G29, 20G31, 20H01, 20H05, 20H26, 20H27, 20H29, 20L27, 20L28, 20M03, 20M19, 20M23, 20M25, 20M26, 21A16, 21A19, 21B04, 21B06, 21B10, 21B18, 21B20, 21B25, 21C11, 21C13, 21C17, 21D07, 21D08, 21D10, 21D29, 21F19, 21F23, 21F24, 21F25, 21F26, 21F30, 21G08, 21G09, 21G10, 21G14, 21G17, 21G20, 21G21, 21H05, 21H06, 21H07, 21H26, 21H28, 21I04, 21I22, 21I26, 21K07, 21K09, 21K13, 21K29, 21K30, 21L16, 21L17, 21L18, 21L19, 21L20, 21L30, 21M02, 21M03, 21M11, 21M14, 22A08, 22A25, 22B25, 22B27, 22C02, 22C03, 22C25, 22C29, 22D14, 22D15, 22D19, 22D21, 22F02, 22F04, 22G14, 22G16, 22G21, 22G23, 22G29, 22H25, 22I01, 22I03, 22I08, 22I28, 22K01, 22K05, 22K16, 22K18, 22K19, 22K20, 22L01, 22L02, 22L15, 22L16, 22M06, 22M15, 22M17, 23A08, 23A11, 23A31, 23B01, 23B07, 23B25, 23B28, 23C16, 23C18, 23C21, 23D19, 23D22, 23D28, 23F07, 23F30, 23G07, 23G11, 23G29, 23H01, 23I05, 23I06, 23I07, 23I23, 23I26, 23I28, 23I29, 23K18, 23K19,",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the country of Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}