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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2467-2025.jsonld",
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  "name": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1)  A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;   2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;   3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;   4) CYSTO PACK, Model/Item Number HSCY13M;   5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;   6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;   7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;   8) PDA LF SJW, Model/Item Number SWPD12K;   9) AAA PACK - 206038, Model/Item Number UDAA63AH;   10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;   11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;   12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;   13) PROCUREMENT PACK, Model/Item Number UIPC89D;   14) THYROID PACK (PS 096552), Model/Item Number UITR45W;   15) TRAUMA PACK 175634, Model/Item Number UMTR17B;   16) TRAUMA PACK 175634, Model/Item Number UMTR17C.",
  "description": "FDA recall Z-2467-2025 — American Contract Systems Inc is recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1)  A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;   2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;   3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;   4) CYSTO PACK, Model/Item Number HSCY13M;   5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;   6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;   7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;   8) PDA LF SJW, Model/Item Number SWPD12K;   9) AAA PACK - 206038, Model/Item Number UDAA63AH;   10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;   11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;   12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;   13) PROCUREMENT PACK, Model/Item Number UIPC89D;   14) THYROID PACK (PS 096552), Model/Item Number UITR45W;   15) TRAUMA PACK 175634, Model/Item Number UMTR17B;   16) TRAUMA PACK 175634, Model/Item Number UMTR17C. (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1)  A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;   2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;   3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;   4) CYSTO PACK, Model/Item Number HSCY13M;   5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;   6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;   7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;   8) PDA LF SJW, Model/Item Number SWPD12K;   9) AAA PACK - 206038, Model/Item Number UDAA63AH;   10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;   11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;   12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;   13) PROCUREMENT PACK, Model/Item Number UIPC89D;   14) THYROID PACK (PS 096552), Model/Item Number UITR45W;   15) TRAUMA PACK 175634, Model/Item Number UMTR17B;   16) TRAUMA PACK 175634, Model/Item Number UMTR17C.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2467-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2467-2025: American Contract Systems Inc is recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1)  A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;   2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;   3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;   4) CYSTO PACK, Model/Item Number HSCY13M;   5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;   6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;   7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;   8) PDA LF SJW, Model/Item Number SWPD12K;   9) AAA PACK - 206038, Model/Item Number UDAA63AH;   10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;   11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;   12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;   13) PROCUREMENT PACK, Model/Item Number UIPC89D;   14) THYROID PACK (PS 096552), Model/Item Number UITR45W;   15) TRAUMA PACK 175634, Model/Item Number UMTR17B;   16) TRAUMA PACK 175634, Model/Item Number UMTR17C.",
      "text": "The FDA logged enforcement record Z-2467-2025: American Contract Systems Inc is voluntarily recalling AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1)  A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;   2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;   3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G;   4) CYSTO PACK, Model/Item Number HSCY13M;   5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K;   6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H;   7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D;   8) PDA LF SJW, Model/Item Number SWPD12K;   9) AAA PACK - 206038, Model/Item Number UDAA63AH;   10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF;   11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX;   12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD;   13) PROCUREMENT PACK, Model/Item Number UIPC89D;   14) THYROID PACK (PS 096552), Model/Item Number UITR45W;   15) TRAUMA PACK 175634, Model/Item Number UMTR17B;   16) TRAUMA PACK 175634, Model/Item Number UMTR17C. — reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-14. Affected lots/codes: 1)   Model/Item Number ANCV67X:  UDI/DI 00191072203021, Kit Lot Numbers:  42-7789611, 42-8074911, 42-7925811, 42-8005111;  2)  Model/Item Number ANKP15AD:  UDI/DI 00191072235176, Kit Lot Numbers:  42-7916611, 42-8047711;  3)  Model/Item Number FYLA38G:  UDI/DI 00191072003706, Kit Lot Numbers:  42-7905711, 42-8134111;  4)  Model/Item Number HSCY13M:  UDI/DI 00191072005571, Kit Lot Numbers:  42-8125311, 42-7959411;  5)  Model/Item Number HSDR10K:  UDI/DI 00191072005588, Kit Lot Numbers:  42-7984111, 42-7883711;  6)  Model/Item Number HSMD20H:  UDI/DI 00191072237262, Kit Lot Numbers:  42-7937911;  7)  Model/Item Number PDSA12D:  UDI/DI 00191072137111, Kit Lot Numbers:  70-053496;  8)  Model/Item Number SWPD12K:  UDI/DI 00191072228512, Kit Lot Numbers:  5437920, 5436824, 5436860, 5437058, 5437174, 5437197, 5437211, 5437326, 5437390, 5437696, 5437720, 5437752, 5437800, 5437859, 5438008, 5438056, 5438066, 5438331, 5438336, 5438446, 5438033 , 5438535;  9)  Model/Item Number UDAA63AH:  UDI/DI 00191072235275, Kit Lot Numbers:  42-8052111, 42-8104211;  10)  Model/Item Number UDBC35AF:  UDI/DI 00191072103420, Kit Lot Numbers:  42-7867111, 42-7940911, 42-7981511;  11)  Model/Item Number UDBH37AX:  UDI/DI 00191072012098, Kit Lot Numbers:  42-7867811, 42-7947511, 42-8007611, 42-8032411;  12)  Model/Item Number UIFF72AD:  UDI/DI 00191072235541, Kit Lot Numbers:  42-7849111, 42-7947711, 42-8024111, 42-8095211;  13)  Model/Item Number UIPC89D:  UDI/DI 00191072205742, Kit Lot Numbers:  42-8024311, 42-8113911;  14)  Model/Item Number UITR45W:  UDI/DI 00191072235589, Kit Lot Numbers:  42-7875311, 42-7980811, 42-8067111;  15)  Model/Item Number UMTR17B:  UDI/DI 00191072222596, Kit Lot Numbers:  9124674, 8925186, 9003138, 9051991 16)  Model/Item Number UMTR17C:  UDI/DI 00191072233806, Kit Lot Numbers:  \" 9202780, 9292532.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
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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-2467-2025&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-2467-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2467-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2467-2025 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": {
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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-2467-2025&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-2467-2025&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-2467-2025/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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2467-2025",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2467-2025",
            "Status": "recorded"
          }
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          "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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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-07-14",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1)   Model/Item Number ANCV67X:  UDI/DI 00191072203021, Kit Lot Numbers:  42-7789611, 42-8074911, 42-7925811, 42-8005111;  2)  Model/Item Number ANKP15AD:  UDI/DI 00191072235176, Kit Lot Numbers:  42-7916611, 42-8047711;  3)  Model/Item Number FYLA38G:  UDI/DI 00191072003706, Kit Lot Numbers:  42-7905711, 42-8134111;  4)  Model/Item Number HSCY13M:  UDI/DI 00191072005571, Kit Lot Numbers:  42-8125311, 42-7959411;  5)  Model/Item Number HSDR10K:  UDI/DI 00191072005588, Kit Lot Numbers:  42-7984111, 42-7883711;  6)  Model/Item Number HSMD20H:  UDI/DI 00191072237262, Kit Lot Numbers:  42-7937911;  7)  Model/Item Number PDSA12D:  UDI/DI 00191072137111, Kit Lot Numbers:  70-053496;  8)  Model/Item Number SWPD12K:  UDI/DI 00191072228512, Kit Lot Numbers:  5437920, 5436824, 5436860, 5437058, 5437174, 5437197, 5437211, 5437326, 5437390, 5437696, 5437720, 5437752, 5437800, 5437859, 5438008, 5438056, 5438066, 5438331, 5438336, 5438446, 5438033 , 5438535;  9)  Model/Item Number UDAA63AH:  UDI/DI 00191072235275, Kit Lot Numbers:  42-8052111, 42-8104211;  10)  Model/Item Number UDBC35AF:  UDI/DI 00191072103420, Kit Lot Numbers:  42-7867111, 42-7940911, 42-7981511;  11)  Model/Item Number UDBH37AX:  UDI/DI 00191072012098, Kit Lot Numbers:  42-7867811, 42-7947511, 42-8007611, 42-8032411;  12)  Model/Item Number UIFF72AD:  UDI/DI 00191072235541, Kit Lot Numbers:  42-7849111, 42-7947711, 42-8024111, 42-8095211;  13)  Model/Item Number UIPC89D:  UDI/DI 00191072205742, Kit Lot Numbers:  42-8024311, 42-8113911;  14)  Model/Item Number UITR45W:  UDI/DI 00191072235589, Kit Lot Numbers:  42-7875311, 42-7980811, 42-8067111;  15)  Model/Item Number UMTR17B:  UDI/DI 00191072222596, Kit Lot Numbers:  9124674, 8925186, 9003138, 9051991 16)  Model/Item Number UMTR17C:  UDI/DI 00191072233806, Kit Lot Numbers:  \" 9202780, 9292532.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution to states of:  IL and LA",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}