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  "name": "Catalog Number / Product Description  0601600 2.7F Broviac CV Catheter Repair Kit   0601610 4.2 Fr Broviac CV Catheter Repair Kit   0601620 6.6F Broviac CV Catheter Repair Kit   0601630 9.6F Hickman CV Catheter Repair Kit   0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601700 9F Hickman CV Catheter Repair Kit   0601710 12F Hickman CV Catheter Repair Kit   0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601740 12.5F Hickman CV Catheter Repair Kit   0601750 10F Leonard CV Catheter Repair Kit   0601760 7F Hickman CV Catheter Repair Kit   0601790 10F Hickman CV Catheter Repair Kit",
  "description": "FDA recall Z-1051-2023 — Bard Peripheral Vascular Inc is recalling Catalog Number / Product Description  0601600 2.7F Broviac CV Catheter Repair Kit   0601610 4.2 Fr Broviac CV Catheter Repair Kit   0601620 6.6F Broviac CV Catheter Repair Kit   0601630 9.6F Hickman CV Catheter Repair Kit   0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601700 9F Hickman CV Catheter Repair Kit   0601710 12F Hickman CV Catheter Repair Kit   0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601740 12.5F Hickman CV Catheter Repair Kit   0601750 10F Leonard CV Catheter Repair Kit   0601760 7F Hickman CV Catheter Repair Kit   0601790 10F Hickman CV Catheter Repair Kit (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",
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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-1051-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Catalog Number / Product Description  0601600 2.7F Broviac CV Catheter Repair Kit   0601610 4.2 Fr Broviac CV Catheter Repair Kit   0601620 6.6F Broviac CV Catheter Repair Kit   0601630 9.6F Hickman CV Catheter Repair Kit   0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601700 9F Hickman CV Catheter Repair Kit   0601710 12F Hickman CV Catheter Repair Kit   0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601740 12.5F Hickman CV Catheter Repair Kit   0601750 10F Leonard CV Catheter Repair Kit   0601760 7F Hickman CV Catheter Repair Kit   0601790 10F Hickman CV Catheter Repair Kit",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Bard Peripheral Vascular Inc"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1051-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1051-2023: Bard Peripheral Vascular Inc is recalling Catalog Number / Product Description  0601600 2.7F Broviac CV Catheter Repair Kit   0601610 4.2 Fr Broviac CV Catheter Repair Kit   0601620 6.6F Broviac CV Catheter Repair Kit   0601630 9.6F Hickman CV Catheter Repair Kit   0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601700 9F Hickman CV Catheter Repair Kit   0601710 12F Hickman CV Catheter Repair Kit   0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601740 12.5F Hickman CV Catheter Repair Kit   0601750 10F Leonard CV Catheter Repair Kit   0601760 7F Hickman CV Catheter Repair Kit   0601790 10F Hickman CV Catheter Repair Kit",
      "text": "The FDA logged enforcement record Z-1051-2023: Bard Peripheral Vascular Inc is voluntarily recalling Catalog Number / Product Description  0601600 2.7F Broviac CV Catheter Repair Kit   0601610 4.2 Fr Broviac CV Catheter Repair Kit   0601620 6.6F Broviac CV Catheter Repair Kit   0601630 9.6F Hickman CV Catheter Repair Kit   0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601700 9F Hickman CV Catheter Repair Kit   0601710 12F Hickman CV Catheter Repair Kit   0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)  0601740 12.5F Hickman CV Catheter Repair Kit   0601750 10F Leonard CV Catheter Repair Kit   0601760 7F Hickman CV Catheter Repair Kit   0601790 10F Hickman CV Catheter Repair Kit — reason: Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-04. Affected lots/codes: Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198  / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720  / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)00801741036453(17)240229(10)REGQ1174 0601740 / REFZ0223 / (01)00801741036460(17)230930(10)REFZ0223 0601750 / REFY0744 / (01)00801741036477(17)230731(10)REFY0744 0601760 / REEU1534 / (01)00801741036484(17)230630(10)REEU1534 0601790 / REFW1651 / (01)00801741036514(17)231031(10)REFW1651 7741700 / REET0877 / (01)00801741036798(17)240131(10)REET0877 7741800 / REER0703 / (01)00801741036804(17)240531(10)REER0703 7741800 / REFW3156 / (01)00801741036804(17)250131(10)REFW3156 0601600 / REES06790 / (01)00801741036378(17)220831(10)REES0679 0601600 / REES2528 / (01)00801741036378(17)220831(10)REES2528 0601600 / REES3456 / (01)00801741036378(17)220831(10)REES3456 0601610 / REEQ1683 / (01)00801741036385(17)220831(10)REEQ1683 0601610 / REEQ4180 / (01)00801741036385(17)220831(10)REEQ4180 0601610 / REER3748 / (01)00801741036385(17)220831(10)REER3748 0601610 / REES0715 / (01)00801741036385(17)220831(10)REES0715 0601610 / REET3287 / (01)00801741036385(17)220831(10)REET3287 0601620 / REEQ2751 / (01)00801741074479(17)220831(10)REEQ2751 0601620 / REEQ4141 / (01)00801741074479(17)220831(10)REEQ4141 0601620 / REER3694 / (01)00801741074479(17)220831(10)REER3694 0601620 / REET3269 / (01)00801741074479(17)220831(10)REET3269 0601630 / REEU0729 / (01)00801741036408(17)220831(10)REEU0729 0601630 / REEU3297 / (01)00801741036408(17)220831(10)REEU3297 0601690 / REEU0727 / (01)00801741036422(17)220831(10)REEU0727 0601700 / REER3695 / (01)00801741036439(17)220831(10)REER3695 0601710 / REER3750 / (01)00801741036446(17)220831(10)REER3750 0601710 / REEU3314 / (01)00801741036446(17)220831(10)REEU3314 0601740 / REEU3298 / (01)00801741036460(17)220831(10)REEU3298 0601750 / REEU0730 / (01)00801741036477(17)220831(10)REEU0730 0601750 / REEU1608 / (01)00801741036477(17)220831(10)REEU1608 0601760 / REER3696 / (01)00801741036484(17)220831(10)REER3696 0601760 / REES3457 / (01)00801741036484(17)220831(10)REES3457 0601760 / REET2794 / (01)00801741036484(17)220831(10)REET2794 0601760 / REEU1184 / (01)00801741036484(17)220831(10)REEU1184. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1051-2023&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-1051-2023&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1051-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1051-2023 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-1051-2023&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-1051-2023&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-1051-2023/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-1051-2023",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1051-2023",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
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        {
          "@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": "Bard Peripheral Vascular Inc",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-01-04",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198  / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720  / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)00801741036453(17)240229(10)REGQ1174 0601740 / REFZ0223 / (01)00801741036460(17)230930(10)REFZ0223 0601750 / REFY0744 / (01)00801741036477(17)230731(10)REFY0744 0601760 / REEU1534 / (01)00801741036484(17)230630(10)REEU1534 0601790 / REFW1651 / (01)00801741036514(17)231031(10)REFW1651 7741700 / REET0877 / (01)00801741036798(17)240131(10)REET0877 7741800 / REER0703 / (01)00801741036804(17)240531(10)REER0703 7741800 / REFW3156 / (01)00801741036804(17)250131(10)REFW3156 0601600 / REES06790 / (01)00801741036378(17)220831(10)REES0679 0601600 / REES2528 / (01)00801741036378(17)220831(10)REES2528 0601600 / REES3456 / (01)00801741036378(17)220831(10)REES3456 0601610 / REEQ1683 / (01)00801741036385(17)220831(10)REEQ1683 0601610 / REEQ4180 / (01)00801741036385(17)220831(10)REEQ4180 0601610 / REER3748 / (01)00801741036385(17)220831(10)REER3748 0601610 / REES0715 / (01)00801741036385(17)220831(10)REES0715 0601610 / REET3287 / (01)00801741036385(17)220831(10)REET3287 0601620 / REEQ2751 / (01)00801741074479(17)220831(10)REEQ2751 0601620 / REEQ4141 / (01)00801741074479(17)220831(10)REEQ4141 0601620 / REER3694 / (01)00801741074479(17)220831(10)REER3694 0601620 / REET3269 / (01)00801741074479(17)220831(10)REET3269 0601630 / REEU0729 / (01)00801741036408(17)220831(10)REEU0729 0601630 / REEU3297 / (01)00801741036408(17)220831(10)REEU3297 0601690 / REEU0727 / (01)00801741036422(17)220831(10)REEU0727 0601700 / REER3695 / (01)00801741036439(17)220831(10)REER3695 0601710 / REER3750 / (01)00801741036446(17)220831(10)REER3750 0601710 / REEU3314 / (01)00801741036446(17)220831(10)REEU3314 0601740 / REEU3298 / (01)00801741036460(17)220831(10)REEU3298 0601750 / REEU0730 / (01)00801741036477(17)220831(10)REEU0730 0601750 / REEU1608 / (01)00801741036477(17)220831(10)REEU1608 0601760 / REER3696 / (01)00801741036484(17)220831(10)REER3696 0601760 / REES3457 / (01)00801741036484(17)220831(10)REES3457 0601760 / REET2794 / (01)00801741036484(17)220831(10)REET2794 0601760 / REEU1184 / (01)00801741036484(17)220831(10)REEU1184",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: U.S.(nationwide): 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, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan.  O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}