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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0173-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item number/ Product description  AHLD15X\tLABOR DELIVERY PACK - 213387  AKDV96B\tVAGINAL DELIVERY  AKDV96B\tVAGINAL DELIVERY  EVBH28D\tBIRTHING ROOM PACK  UPVD01K\tVAGINAL DELIVERY PACK",
  "description": "FDA recall Z-0173-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item number/ Product description  AHLD15X\tLABOR DELIVERY PACK - 213387  AKDV96B\tVAGINAL DELIVERY  AKDV96B\tVAGINAL DELIVERY  EVBH28D\tBIRTHING ROOM PACK  UPVD01K\tVAGINAL DELIVERY PACK (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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  "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-0173-2026&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item number/ Product description  AHLD15X\tLABOR DELIVERY PACK - 213387  AKDV96B\tVAGINAL DELIVERY  AKDV96B\tVAGINAL DELIVERY  EVBH28D\tBIRTHING ROOM PACK  UPVD01K\tVAGINAL DELIVERY PACK",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0173-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0173-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item number/ Product description  AHLD15X\tLABOR DELIVERY PACK - 213387  AKDV96B\tVAGINAL DELIVERY  AKDV96B\tVAGINAL DELIVERY  EVBH28D\tBIRTHING ROOM PACK  UPVD01K\tVAGINAL DELIVERY PACK",
      "text": "The FDA logged enforcement record Z-0173-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item number/ Product description  AHLD15X\tLABOR DELIVERY PACK - 213387  AKDV96B\tVAGINAL DELIVERY  AKDV96B\tVAGINAL DELIVERY  EVBH28D\tBIRTHING ROOM PACK  UPVD01K\tVAGINAL DELIVERY PACK — reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-04. Affected lots/codes: AHLD15X UDI-DI 191072224767 Lot 8188711 Bag serial no.  17555039 17555044 17555049 17609166 17609181;  AKDV96B UDI-DI 191072224019 Lot 7311311 Bag serial no. 47140875 47141919;  EVBH28D UDI-DI 191072239051 Lot 8424611 Bag serial no. 17754395;  UPVD01K UDI-DI 191072238993 Lot 8439111 Bag serial no.  17682598 Log 8499211 Bag serial no.  17742543. 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-0173-2026&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-0173-2026&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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      "name": "FDA classified recall Z-0173-2026 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.",
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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        }
      },
      "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-0173-2026/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",
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      "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-0173-2026",
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            "Value": "Z-0173-2026",
            "Status": "recorded"
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            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-04",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "AHLD15X UDI-DI 191072224767 Lot 8188711 Bag serial no.  17555039 17555044 17555049 17609166 17609181;  AKDV96B UDI-DI 191072224019 Lot 7311311 Bag serial no. 47140875 47141919;  EVBH28D UDI-DI 191072239051 Lot 8424611 Bag serial no. 17754395;  UPVD01K UDI-DI 191072238993 Lot 8439111 Bag serial no.  17682598 Log 8499211 Bag serial no.  17742543",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
            "Status": "recorded"
          }
        }
      ]
    }
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}