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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1981-2026.jsonld",
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  "name": "Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor    CORONARY ANGIO PACK  Model numbers ANCA80AP  ANCA80AQ",
  "description": "FDA recall Z-1981-2026 — American Contract Systems Inc is recalling Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor    CORONARY ANGIO PACK  Model numbers ANCA80AP  ANCA80AQ (Devices, Class I). 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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1981-2026&lang=eng",
  "about": {
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    "name": "Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor    CORONARY ANGIO PACK  Model numbers ANCA80AP  ANCA80AQ",
    "manufacturer": {
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      "name": "American Contract Systems Inc"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1981-2026/enforcement-record",
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      "name": "FDA recall Z-1981-2026: American Contract Systems Inc is recalling Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor    CORONARY ANGIO PACK  Model numbers ANCA80AP  ANCA80AQ",
      "text": "The FDA logged enforcement record Z-1981-2026: American Contract Systems Inc is voluntarily recalling Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor    CORONARY ANGIO PACK  Model numbers ANCA80AP  ANCA80AQ — reason: Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-19. Affected lots/codes: ANCA80AP UDI-DI 191072232168 Lot 42-8146111  ANCA80AQ UDI-DI 191072236678 Lots  42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911. 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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        "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-1981-2026&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-1981-2026&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-1981-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1981-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I",
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          "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-1981-2026/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,
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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-1981-2026",
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            "Value": "Z-1981-2026",
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            "Value": "Devices",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2026-03-19",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "ANCA80AP UDI-DI 191072232168 Lot 42-8146111  ANCA80AQ UDI-DI 191072236678 Lots  42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution to MN. No OUS distribution.",
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