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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2563-2024.jsonld",
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  "name": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K08-PI (Custom Fluid Management Kit), REF:  K08-02042  K08-02948  K08-03026  K08-03119    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.",
  "description": "FDA recall Z-2563-2024 — Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K08-PI (Custom Fluid Management Kit), REF:  K08-02042  K08-02948  K08-03026  K08-03119    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. (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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "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-2563-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K08-PI (Custom Fluid Management Kit), REF:  K08-02042  K08-02948  K08-03026  K08-03119    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.",
    "manufacturer": {
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      "name": "Merit Medical Systems, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2563-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2563-2024: Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K08-PI (Custom Fluid Management Kit), REF:  K08-02042  K08-02948  K08-03026  K08-03119    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.",
      "text": "The FDA logged enforcement record Z-2563-2024: Merit Medical Systems, Inc. is voluntarily recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K08-PI (Custom Fluid Management Kit), REF:  K08-02042  K08-02948  K08-03026  K08-03119    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. — 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: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347  Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035  Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967  Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "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-2563-2024&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-2563-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2563-2024/fda-classification",
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      "name": "FDA classified recall Z-2563-2024 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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        "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-2563-2024&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-2563-2024&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-2563-2024/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": {
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        "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-2563-2024",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2563-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "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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          "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: K08-02042 UDI-DI code: 00884450179994 Lot Numbers: H2791360 H2825591 H2832445 H2855331 H2874529 H2897347  Catalog Number: K08-02948 UDI-DI code: 00884450250846 Lot Numbers: H2409549 H2421264 H2454187 H2471302 H2555399 H2560081 H2590001 H2608380 H2616367 H2641745 H2689450 H2718414 H2778302 H2824898 H2835712 H2849743 H2866799 H2875231 H2880035  Catalog Number: K08-03026 UDI-DI code: 00884450280416 Lot Numbers: H2414033 H2437895 H2474035 H2489683 H2518365 H2583262 H2584710 H2596210 H2836476 H2864917 H2881380 H2906069 H2912967  Catalog Number: K08-03119 UDI-DI code: 00884450333716 Lot Numbers: H2424087 H2465222 H2500943 H2519412 H2519413 H2708309 H2744000 H2806045 H2837641 H2846068 H2865870 H2872906 H2879960 H2912192",
            "Status": "recorded"
          }
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          "position": 9,
          "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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