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  "name": "Procedure packs:    (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;  (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;  (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;  (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;  (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile  (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;  (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;  (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;  (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;  (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;  (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;  (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;  (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and   (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.",
  "description": "FDA recall Z-0086-2024 — Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;  (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;  (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;  (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;  (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile  (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;  (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;  (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;  (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;  (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;  (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;  (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;  (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and   (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile. (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",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0086-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Procedure packs:    (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;  (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;  (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;  (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;  (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile  (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;  (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;  (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;  (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;  (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;  (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;  (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;  (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and   (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Cardinal Health 200, LLC"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0086-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0086-2024: Cardinal Health 200, LLC is recalling Procedure packs:    (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;  (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;  (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;  (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;  (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile  (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;  (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;  (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;  (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;  (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;  (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;  (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;  (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and   (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile.",
      "text": "The FDA logged enforcement record Z-0086-2024: Cardinal Health 200, LLC is voluntarily recalling Procedure packs:    (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile;   (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit, Robot Surg Onc, Sterile;  (4) Presource PBDS Cat. PUMHCCESP, Southeast Hospital MHHS, Kit, Cystoscopy, SE, Sterile;  (5) Presource General Laparoscopy Pack, Cat. SBA18GLEFF, St. Elizabeth Medical Center, Sterile;  (6) Presource IUS Perc 1 Pk, Cat. SOTCGPPMEA, IU Health Methodist Hospital, Sterile;  (7) Presource Cysto Pack, Cat. SOT18CYEFC, St. Elizabeth Medical Center; Sterile  (8) Presource GU PUP Pack, Cat. SOT29GUHCD, Hillcrest Hospital, Sterile;  (9) Presource PCNL Pack, Cat. SOT30PENBB, North Bay Regional Hlth Ctr, Sterile;  (10) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO13, Ohio State Univ Wexner Med Ctr., Sterile;  (11) Presource Percu Nephros Lithotomy UH Pk, Cat. SOT33PNO15, Ohio State Univ Wexner Med Ctr., Sterile;  (12) Presource PNL Cysto Pack, Cat. SOT51CPKOA, KP Oakland Med Center, Sterile;  (13) Presource PNL Cysto Pack, Cat. SOT51CPK10, KP Oakland Med Center, Sterile;  (14) Presource PCN Pack, Cat. SOT69PCKSA, KP Los Angeles Med Center, Sterile;  (15) Presource Perc Neph Pack, Cat. SOT7APNLVB, Lehigh Valley Hospital, Sterile; and   (16) Presource Cysto Pack, Cat. SOT73CPKSB, KP Zion Med Cntr, Sterile. — reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-08-16. Affected lots/codes: (1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130;  (2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419;  (3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930;  (4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153; (5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209; (6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475; (7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216; (8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811;  (9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707;  (10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452;  (11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619;  (12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795;  (13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418;  (14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071;  (15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and (16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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      "commercialInfluence": false,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0086-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0086-2024&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-0086-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0086-2024 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
      },
      "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-0086-2024&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-0086-2024&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-0086-2024/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."
    }
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      "name": "FDA recall details — Z-0086-2024",
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            "Value": "Z-0086-2024",
            "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": "Cardinal Health 200, LLC",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-08-16",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "(1) Cat. PG33BTO21 - Lot #914590, Exp. 6/1/2024, UDI-DI 10195594884130;  (2) Cat. PG33BTO22 - Lot #928313, Exp. 2/1/2024, UDI-DI 10197106010419;  (3) Cat. PG33SROUB - Lot #81580, Exp. 12/1/2024, UDI-DI 10197106186930;  (4) Cat. PUMHCCESP - Lot #4316, Exp. 2/1/2025 and 9/1/2025, UDI-DI 10195594542153; (5) Cat. SBA18GLEFF - Lot #895495, Exp. 6/1/2025 and Exp. 7/1/2025, UDI-DI 10888439910209; (6) Cat. SOTCGPPMEA - Lot #984246, Exp. 7/1/2025 and Exp. 5/1/2024, UDI-DI 10888439847475; (7) Cat. SOT18CYEFC - Lot #928044, Exp. 4/1/2027, UDI-DI 10888439910216; (8) Cat. SOT29GUHCD - Lot #986052, Exp. 6/1/2027, UDI-DI 10195594963811;  (9) Cat. SOT30PENBB - Lot #987163, Exp. 8/1/2025, UDI-DI 10888439948707;  (10) Cat. SOT33PNO13 - Lot #920956, Exp. 8/1/2024, UDI-DI 10195594887452;  (11) Cat. SOT33PNO15 - Lot #966904, Exp. 6/1/2024, UDI-DI 10197106087619;  (12) Cat. SOT51CPKOA - Lot #916606, Exp. 11/1/2023, UDI-DI 10887488777795;  (13) Cat. SOT51CPK10 - Lot #997330, Exp. 2/1/2024, UDI-DI 10197106161418;  (14) Cat. SOT69PCKSA - Lot #997386, Exp. 3/1/2024, UDI-DI 10888439898071;  (15) Cat. SOT7APNLVB - Lot #930337, Exp. 5/1/2024, UDI-DI 10888439925708; and (16) Cat. SOT73CPKSB - Lot #923138 Exp. 1/1/2025, UDI-DI 10888439906561.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV.  There was government distribution and no military distribution. The country of Canada.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}