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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0316-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S",
  "description": "FDA recall Z-0316-2024 — Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S (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,
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  "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-0316-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Atrium Medical Corporation"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0316-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0316-2024: Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S",
      "text": "The FDA logged enforcement record Z-0316-2024: Atrium Medical Corporation is voluntarily recalling Ocean Water Seal Chest Drains (Ocean):  Products REF Number Product Name   (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;   (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;  (3)2002-100 DRAIN, OCEAN SINGLE W/AC;   (4)2002-300 DRAIN, OCEAN SINGLE W/S;   (5) 2002-400 DRAIN, OCEAN SINGLE ;  (6)2012-320 DRAIN, OCEAN PEDI W/S;  (7)2050-000 DRAIN, OCEAN BRU W/AC,S — reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of  catheter(s) and patient tube connections with single collection chamber chest drains. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-18. Affected lots/codes: 1)2002-000 DRAIN, OCEAN SINGLE W/AC,S 20650862100017 (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN, OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN, OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN, OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN, OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN, OCEAN BRU W/AC,S 20650862103018  All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "supported": true,
        "adjudged": 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-0316-2024&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-0316-2024&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-0316-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0316-2024 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
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-0316-2024&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-0316-2024/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
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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."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0316-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0316-2024",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "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"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Atrium Medical Corporation",
            "Status": "recorded"
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        },
        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of  catheter(s) and patient tube connections with single collection chamber chest drains",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-09-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1)2002-000 DRAIN, OCEAN SINGLE W/AC,S 20650862100017 (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN, OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN, OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN, OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN, OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN, OCEAN BRU W/AC,S 20650862103018  All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria,  Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel,  Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia,  Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan,  Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore,  Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}