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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2577-2024.jsonld",
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  "name": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:  FCL-083-02/A  WOR-CSG-B1-09/A  WOR-CSG-B2-09/A  WOR-CSG-BL1-09/A  WOR-CSG-E-90/A    For the introduction of various types of pacing or defibrillator leads and catheters.",
  "description": "FDA recall Z-2577-2024 — Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:  FCL-083-02/A  WOR-CSG-B1-09/A  WOR-CSG-B2-09/A  WOR-CSG-BL1-09/A  WOR-CSG-E-90/A    For the introduction of various types of pacing or defibrillator leads and catheters. (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-2577-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:  FCL-083-02/A  WOR-CSG-B1-09/A  WOR-CSG-B2-09/A  WOR-CSG-BL1-09/A  WOR-CSG-E-90/A    For the introduction of various types of pacing or defibrillator leads and catheters.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Merit Medical Systems, Inc."
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  "claims": [
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2577-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2577-2024: Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:  FCL-083-02/A  WOR-CSG-B1-09/A  WOR-CSG-B2-09/A  WOR-CSG-BL1-09/A  WOR-CSG-E-90/A    For the introduction of various types of pacing or defibrillator leads and catheters.",
      "text": "The FDA logged enforcement record Z-2577-2024: Merit Medical Systems, Inc. is voluntarily recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:  FCL-083-02/A  WOR-CSG-B1-09/A  WOR-CSG-B2-09/A  WOR-CSG-BL1-09/A  WOR-CSG-E-90/A    For the introduction of various types of pacing or defibrillator leads and catheters. — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-11. Affected lots/codes: Catalog Number/UDI-DI code/Lot Numbers:  FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690  WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927  WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183  WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321  WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689. A RECORDED FDA enforcement action (occurred=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-2577-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-2577-2024&lang=eng"
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      "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-2577-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2577-2024 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,
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      "grounding": {
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        "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-2577-2024&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-2577-2024/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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "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-2577-2024",
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            "Field": "Recall number",
            "Value": "Z-2577-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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            "Value": "Class II",
            "Status": "determination"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Merit Medical Systems, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-06-11",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number/UDI-DI code/Lot Numbers:  FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690  WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927  WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183  WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321  WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.",
            "Status": "recorded"
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