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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1188-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,     BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.      Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.",
  "description": "FDA recall Z-1188-2023 — Maquet Medical Systems USA is recalling BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,     BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.      Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support. (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/",
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  "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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1188-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,     BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.      Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Maquet Medical Systems USA"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1188-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1188-2023: Maquet Medical Systems USA is recalling BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,     BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.      Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.",
      "text": "The FDA logged enforcement record Z-1188-2023: Maquet Medical Systems USA is voluntarily recalling BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077,     BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078.      Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support. — reason: Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-02-13. Affected lots/codes: HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355  HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383  All lots/batches affected. 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-1188-2023&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-1188-2023&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-1188-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1188-2023 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
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      "grounding": {
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        "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-1188-2023&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-1188-2023&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-1188-2023/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-1188-2023",
      "numberOfItems": 9,
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            "Value": "Z-1188-2023",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Maquet Medical Systems USA",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.",
            "Status": "recorded"
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        },
        {
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          "item": {
            "Field": "Initiated",
            "Value": "2023-02-13",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355  HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383  All lots/batches affected",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Myanmar, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of North Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Republic of Korea, The Russian Federation, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
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}