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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1176-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "3M V.A.C. VIA Negative Pressure Wound Therapy System  REF:  VIAKIT077D01/US - V.A.C. VIA 7 Day Kit  VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack  VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper",
  "description": "FDA recall Z-1176-2025 — KCI USA, INC. is recalling 3M V.A.C. VIA Negative Pressure Wound Therapy System  REF:  VIAKIT077D01/US - V.A.C. VIA 7 Day Kit  VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack  VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper (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-1176-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "3M V.A.C. VIA Negative Pressure Wound Therapy System  REF:  VIAKIT077D01/US - V.A.C. VIA 7 Day Kit  VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack  VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "KCI USA, INC."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1176-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1176-2025: KCI USA, INC. is recalling 3M V.A.C. VIA Negative Pressure Wound Therapy System  REF:  VIAKIT077D01/US - V.A.C. VIA 7 Day Kit  VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack  VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper",
      "text": "The FDA logged enforcement record Z-1176-2025: KCI USA, INC. is voluntarily recalling 3M V.A.C. VIA Negative Pressure Wound Therapy System  REF:  VIAKIT077D01/US - V.A.C. VIA 7 Day Kit  VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack  VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper — reason: Due to increase in complaints related to leak alarms. Status: Ongoing — the recall is still being carried out.. Initiated 2025-01-17. Affected lots/codes: VIAKIT077D01/US V.A.C. VIA 7 DAY KIT UDI-DI code: 00849554002388 Assembly Item Number: VIAKIT077D01/USV003 Lot Numbers: C17525V003 C17557V003  VIAKIT07S05/AU V.A.C. VIA STARTER KIT 5-PACK UDI-DI code: 00849554002401 Assembly Item Number: VIAKIT07S05/AUV003 Lot Number: C16937V003  VIAKIT077D01/GB V.A.C. VIA 7 DAY KIT, SINGLE SHIPPER UDI-DI code: 00849554002364 Assembly Item Number: VIAKIT077D01/GBV003 Lot  Numbers: C16936V003 C17027V003. 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-1176-2025&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-1176-2025&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1176-2025/fda-classification",
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      "name": "FDA classified recall Z-1176-2025 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)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1176-2025&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-1176-2025&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-1176-2025/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-1176-2025",
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            "Value": "Z-1176-2025",
            "Status": "recorded"
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          "item": {
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            "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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "KCI USA, INC.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to increase in complaints related to leak alarms",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-01-17",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "VIAKIT077D01/US V.A.C. VIA 7 DAY KIT UDI-DI code: 00849554002388 Assembly Item Number: VIAKIT077D01/USV003 Lot Numbers: C17525V003 C17557V003  VIAKIT07S05/AU V.A.C. VIA STARTER KIT 5-PACK UDI-DI code: 00849554002401 Assembly Item Number: VIAKIT07S05/AUV003 Lot Number: C16937V003  VIAKIT077D01/GB V.A.C. VIA 7 DAY KIT, SINGLE SHIPPER UDI-DI code: 00849554002364 Assembly Item Number: VIAKIT077D01/GBV003 Lot  Numbers: C16936V003 C17027V003",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY.  The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}