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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1350-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661",
  "description": "FDA recall Z-1350-2024 — ConvaTec, Inc is recalling Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661 (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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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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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-1350-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ConvaTec, Inc"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1350-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1350-2024: ConvaTec, Inc is recalling Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661",
      "text": "The FDA logged enforcement record Z-1350-2024: ConvaTec, Inc is voluntarily recalling Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF):  a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660, t) 423661 — reason: Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-19. Affected lots/codes: a) 423643, UDI/DI 768455203925, Lot Numbers 3L03391;  b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005;  c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670;  d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230;  e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004;  f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989;  g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674;  h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114;  i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669;  j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542;  k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021;  l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786;  m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540;  n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539;  o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541;  p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029;  q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958;  r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888;  s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022;  t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1350-2024&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-1350-2024&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-1350-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1350-2024 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",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
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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-1350-2024&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-1350-2024/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",
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      "epistemicStatus": {
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        "supported": 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-1350-2024",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1350-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "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": "ConvaTec, Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.",
            "Status": "recorded"
          }
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        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-02-19",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) 423643, UDI/DI 768455203925, Lot Numbers 3L03391;  b) 423658, UDI/DI 768455204076, Lot Numbers 3L04005;  c) 423659, UDI/DI 768455204083, Lot Numbers 3L03670;  d) 423664, UDI/DI 768455204137, Lot Numbers 3L02230;  e) 423666, UDI/DI 768455204151, Lot Numbers 3L04004;  f) 423645, UDI/DI 976845520394, Lot Numbers 3L04989;  g) 423667, UDI/DI 768455204168, Lot Numbers 3L04674;  h) 423657, UDI/DI 768455204069, Lot Numbers 3L04114;  i) 423652, UDI/DI 768455204014, Lot Numbers 3L03669;  j) 423646, UDI/DI 768455203956, Lot Numbers 3M01542;  k) 423654, UDI/DI 768455204038, Lot Numbers 3M00021;  l) 423653, UDI/DI 768455204021, Lot Numbers 3M00786;  m) 423647, UDI/DI 768455203963, Lot Numbers 3M01540;  n) 423644, UDI/DI 768455203932, Lot Numbers 3M01539;  o) 423648, UDI/DI 768455203970, Lot Numbers 3M01541;  p) 423665, UDI/DI 768455204144, Lot Numbers 3M00029;  q) 423656, UDI/DI 768455204052, Lot Numbers 3L00958;  r) 423651, UDI/DI 768455204007, Lot Numbers 3K03888;  s) 423660, UDI/DI 768455204090, Lot Numbers 3M00022;  t) 423661, UDI/DI 768455204106, Lot Numbers 3M00023",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Italy, UK.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}