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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1267-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:    a) REF AK-04220;   b) REF ASK-04220-FMH1;   c) REF ASK-04220-HHC;   d) REF ASK-04220-KSP;   e) REF ASK-04220-PSU;   f) REF ASK-04220-UCL1;   g) REF ASK-04500-AH;   h) REF ASK-04500-HF-S;   i) REF NA-04220-S1A;   j) REF NA-04220-X1A;   k) REF RA-04220;   l) REF RA-04220-W",
  "description": "FDA recall Z-1267-2024 — ARROW INTERNATIONAL Inc. is recalling ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:    a) REF AK-04220;   b) REF ASK-04220-FMH1;   c) REF ASK-04220-HHC;   d) REF ASK-04220-KSP;   e) REF ASK-04220-PSU;   f) REF ASK-04220-UCL1;   g) REF ASK-04500-AH;   h) REF ASK-04500-HF-S;   i) REF NA-04220-S1A;   j) REF NA-04220-X1A;   k) REF RA-04220;   l) REF RA-04220-W (Devices, Class I). 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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  "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": {
      "@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-1267-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:    a) REF AK-04220;   b) REF ASK-04220-FMH1;   c) REF ASK-04220-HHC;   d) REF ASK-04220-KSP;   e) REF ASK-04220-PSU;   f) REF ASK-04220-UCL1;   g) REF ASK-04500-AH;   h) REF ASK-04500-HF-S;   i) REF NA-04220-S1A;   j) REF NA-04220-X1A;   k) REF RA-04220;   l) REF RA-04220-W",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "ARROW INTERNATIONAL Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1267-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1267-2024: ARROW INTERNATIONAL Inc. is recalling ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:    a) REF AK-04220;   b) REF ASK-04220-FMH1;   c) REF ASK-04220-HHC;   d) REF ASK-04220-KSP;   e) REF ASK-04220-PSU;   f) REF ASK-04220-UCL1;   g) REF ASK-04500-AH;   h) REF ASK-04500-HF-S;   i) REF NA-04220-S1A;   j) REF NA-04220-X1A;   k) REF RA-04220;   l) REF RA-04220-W",
      "text": "The FDA logged enforcement record Z-1267-2024: ARROW INTERNATIONAL Inc. is voluntarily recalling ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:    a) REF AK-04220;   b) REF ASK-04220-FMH1;   c) REF ASK-04220-HHC;   d) REF ASK-04220-KSP;   e) REF ASK-04220-PSU;   f) REF ASK-04220-UCL1;   g) REF ASK-04500-AH;   h) REF ASK-04500-HF-S;   i) REF NA-04220-S1A;   j) REF NA-04220-X1A;   k) REF RA-04220;   l) REF RA-04220-W — reason: Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component.  The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-12. Affected lots/codes: a) REF AK-04220, UDI/DI 20801902190943, Lot Numbers:  13F22E0436, 13F22H0360, 33F23E0375, 33F23K0032, 33F23J0443, 33F23L0862; UDI/DI 30801902121616, Lot Numbers:  13F22L0105, 13F23A0651, 33F23C0100, 33F23F0347, 33F23E0501, 33F23G0141;   b) REF ASK-04220-FMH1, UDI/DI 20801902111665, Lot Numbers:  33F23B0525, 33F23H0100;   c) REF ASK-04220-HHC, UDI/DI 20801902190851, Lot Numbers:  33F23F0067, 33F23K0278, 33F23G0478, 33F23H0101;   d) REF ASK-04220-KSP, UDI/DI 20801902156406, Lot Numbers:  33F23E0709, 33F23H0102, 33F23H0918, 33F23J0607;   e) REF ASK-04220-PSU, UDI/DI 40801902121446, Lot Numbers:  33F23F0331, 33F23G0663;   f) REF ASK-04220-UCL1, UDI/DI 20801902159124, Lot Numbers:  33F23F0801, 33F23C0726, 33F23H0320;   g) REF ASK-04500-AH, UDI/DI 20801902114048, Lot Numbers:  33F23E0731, 33F23H0103, 33F23H0395;   h) REF ASK-04500-HF-S, UDI/DI 40801902118002, Lot Numbers:  33F23F0202, 33F23H0104, 33F23H0396;   i) REF NA-04220-S1A, UDI/DI 20801902139416, Lot Numbers:  33F23J0671;   j) REF NA-04220-X1A, UDI/DI 20801902136606, Lot Numbers:  33F23F0704;   k) REF RA-04220, UDI/DI 20801902180678, Lot Numbers:  14F23B0041; UDI/DI 30801902193309, Lot Numbers:  14F21L0189, 14F21L0190, 14F21L0250, 14F21L0251, 14F21L0252, 14F21L0253, 14F21M0130, 14F21M0131, 14F21M0205, 14F21M0206, 14F22A0044, 14F22A0123, 14F22A0124, 14F22A0143, 14F22A0144, 14F22B0163, 14F22B0164, 14F22B0175, 14F22C0017, 14F22C0018, 14F22C0019, 14F22C0020, 14F22C0021, 14F22C0022, 14F22C0216, 14F22C0284, 14F22C0346, 14F22C0347, 14F22D0023, 14F22D0024, 14F22D0110, 14F22D0217, 14F22D0291, 14S22D0218, 14F22E0016, 14F22E0173, 14F22E0215, 14F22F0003, 14F22F0062, 14F22F0208, 14F22F0209, 14F22F0210, 14F22F0212, 14F22F0335, 14F22F0336, 14F22G0297, 14F22G0298, 14F22G0325, 14F22G0326, 14F22H0078, 14F22H0079, 14F22H0250, 14F22J0078, 14F22J0079, 14F22J0080, 14F22J0081, 14F22J0082, 14F22J0083, 14F22J0257; UDI/DI 30801902210631, Lot Numbers:  14F22K0182, 14F22K0183, 14F22K0184, 14F22K0185, 14F22K0223, 14F22M0032, 14F22M0033, 14F22M0034, 14F22M0035, 14F22M0036, 14F22M0132, 14F23B0042, 14F23B0142, 14F23B0143, 14F23B0144, 14F23B0154, 14F23D0203, 14F23D0204, 14F23D0205, 14F23D0206, 14F23D0207, 14F23E0093, 14F23E0094, 14F23E0210, 14F23E0211, 14F23F0036, 14F23F0037, 14F23F0038, 14F23F0252, 14F23F0253, 14F23F0377, 14F23F0378, 14F23F0379, 14F23G0147, 14F23G0148, 14F23G0149, 14F23G0150, 14F23G0151, 14F23G0252, 14F23H0087, 14F23H0088, 14F23H0089, 14F23H0090, 14F23H0163, 14F23H0253, 14F23H0254, 14F23H0255, 14F23J0031, 14F23J0032, 14F23J0137, 14F23J0138, 14F23J0276, 14F23J0277;   l) REF RA-04220-W, UDI/DI 30801902193316, Lot Numbers:  13F22E0142, 13F22H0417, 13F22J0586, 13F22M0442, 13F23C0015, 13F23J0017; UDI/DI 30801902202988, Lot Numbers:  13F22F0124, 13F23B0363, 13F23H0010, 13F23J0013, 13F23K0001. 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-1267-2024&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-1267-2024&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-1267-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1267-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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
      },
      "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-1267-2024&lang=eng",
        "value": "Class I",
        "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-1267-2024&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-1267-2024/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": {
        "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-1267-2024",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1267-2024",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "ARROW INTERNATIONAL Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component.  The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-02-12",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) REF AK-04220, UDI/DI 20801902190943, Lot Numbers:  13F22E0436, 13F22H0360, 33F23E0375, 33F23K0032, 33F23J0443, 33F23L0862; UDI/DI 30801902121616, Lot Numbers:  13F22L0105, 13F23A0651, 33F23C0100, 33F23F0347, 33F23E0501, 33F23G0141;   b) REF ASK-04220-FMH1, UDI/DI 20801902111665, Lot Numbers:  33F23B0525, 33F23H0100;   c) REF ASK-04220-HHC, UDI/DI 20801902190851, Lot Numbers:  33F23F0067, 33F23K0278, 33F23G0478, 33F23H0101;   d) REF ASK-04220-KSP, UDI/DI 20801902156406, Lot Numbers:  33F23E0709, 33F23H0102, 33F23H0918, 33F23J0607;   e) REF ASK-04220-PSU, UDI/DI 40801902121446, Lot Numbers:  33F23F0331, 33F23G0663;   f) REF ASK-04220-UCL1, UDI/DI 20801902159124, Lot Numbers:  33F23F0801, 33F23C0726, 33F23H0320;   g) REF ASK-04500-AH, UDI/DI 20801902114048, Lot Numbers:  33F23E0731, 33F23H0103, 33F23H0395;   h) REF ASK-04500-HF-S, UDI/DI 40801902118002, Lot Numbers:  33F23F0202, 33F23H0104, 33F23H0396;   i) REF NA-04220-S1A, UDI/DI 20801902139416, Lot Numbers:  33F23J0671;   j) REF NA-04220-X1A, UDI/DI 20801902136606, Lot Numbers:  33F23F0704;   k) REF RA-04220, UDI/DI 20801902180678, Lot Numbers:  14F23B0041; UDI/DI 30801902193309, Lot Numbers:  14F21L0189, 14F21L0190, 14F21L0250, 14F21L0251, 14F21L0252, 14F21L0253, 14F21M0130, 14F21M0131, 14F21M0205, 14F21M0206, 14F22A0044, 14F22A0123, 14F22A0124, 14F22A0143, 14F22A0144, 14F22B0163, 14F22B0164, 14F22B0175, 14F22C0017, 14F22C0018, 14F22C0019, 14F22C0020, 14F22C0021, 14F22C0022, 14F22C0216, 14F22C0284, 14F22C0346, 14F22C0347, 14F22D0023, 14F22D0024, 14F22D0110, 14F22D0217, 14F22D0291, 14S22D0218, 14F22E0016, 14F22E0173, 14F22E0215, 14F22F0003, 14F22F0062, 14F22F0208, 14F22F0209, 14F22F0210, 14F22F0212, 14F22F0335, 14F22F0336, 14F22G0297, 14F22G0298, 14F22G0325, 14F22G0326, 14F22H0078, 14F22H0079, 14F22H0250, 14F22J0078, 14F22J0079, 14F22J0080, 14F22J0081, 14F22J0082, 14F22J0083, 14F22J0257; UDI/DI 30801902210631, Lot Numbers:  14F22K0182, 14F22K0183, 14F22K0184, 14F22K0185, 14F22K0223, 14F22M0032, 14F22M0033, 14F22M0034, 14F22M0035, 14F22M0036, 14F22M0132, 14F23B0042, 14F23B0142, 14F23B0143, 14F23B0144, 14F23B0154, 14F23D0203, 14F23D0204, 14F23D0205, 14F23D0206, 14F23D0207, 14F23E0093, 14F23E0094, 14F23E0210, 14F23E0211, 14F23F0036, 14F23F0037, 14F23F0038, 14F23F0252, 14F23F0253, 14F23F0377, 14F23F0378, 14F23F0379, 14F23G0147, 14F23G0148, 14F23G0149, 14F23G0150, 14F23G0151, 14F23G0252, 14F23H0087, 14F23H0088, 14F23H0089, 14F23H0090, 14F23H0163, 14F23H0253, 14F23H0254, 14F23H0255, 14F23J0031, 14F23J0032, 14F23J0137, 14F23J0138, 14F23J0276, 14F23J0277;   l) REF RA-04220-W, UDI/DI 30801902193316, Lot Numbers:  13F22E0142, 13F22H0417, 13F22J0586, 13F22M0442, 13F23C0015, 13F23J0017; UDI/DI 30801902202988, Lot Numbers:  13F22F0124, 13F23B0363, 13F23H0010, 13F23J0013, 13F23K0001",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT,  AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}