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  "name": "Medline Sub-G Endotracheal Tube with Subglottic Suctioning:    (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;  (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;  (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID;  (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID;  (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and  (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID.    Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits:    (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case;  (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case;  (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case;  (6)  Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case;  (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case;  (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case.",
  "description": "FDA recall Z-1876-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Sub-G Endotracheal Tube with Subglottic Suctioning:    (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;  (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;  (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID;  (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID;  (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and  (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID.    Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits:    (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case;  (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case;  (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case;  (6)  Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case;  (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case;  (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case. (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.",
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    "@type": "schema:MedicalDevice",
    "name": "Medline Sub-G Endotracheal Tube with Subglottic Suctioning:    (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;  (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;  (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID;  (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID;  (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and  (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID.    Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits:    (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case;  (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case;  (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case;  (6)  Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case;  (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case;  (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case.",
    "manufacturer": {
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1876-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1876-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Sub-G Endotracheal Tube with Subglottic Suctioning:    (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;  (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;  (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID;  (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID;  (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and  (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID.    Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits:    (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case;  (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case;  (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case;  (6)  Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case;  (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case;  (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case.",
      "text": "The FDA logged enforcement record Z-1876-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Sub-G Endotracheal Tube with Subglottic Suctioning:    (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID;  (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID;  (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID;  (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID;  (5) REF DYNJ18880, Polyurethane Cuff 8.0 mm ID; and  (6) REF DYNJ18885, Polyurethane Cuff 8.5 mm ID.    Medline SubG Endotracheal Tube with Subglottic Suctioning packaged into the following convenience kits:    (1) Medline Intubation Kit - Drawer 3, Reorder No. ACC010502, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (2) Medline Intubation Tube - Drawer 3, Reorder No. ACC010527, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 6 kits/case;  (3) Medline Adult Intubation, Reorder No. ACC010540, containing 8.5 size subglottic cuff, 3 kits/case;  (4) Medline Adult Intubation, Reorder No. ACC010540A, containing 8.5 size subglottic cuff, 3 kits/case;  (5) Medline Airway Kit - Drawer 3, Reorder No. ACC010717, containing 6.0, 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 3 kits/case;  (6)  Medline Airway Kit, Reorder No. DYNDJ1132, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 26 kits/case;  (7) Medline Adult Intubation W Evac, Reorder No. DYNDJ1133, containing 7.0, 7.5, and 8.0 sizes subglottic cuff, 10 kits/case;  (8) Medline Backup Kit, Reorder No. DYNJ909501, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (9) Medline Backup Kit, Reorder No. DYNJ909501A, containing 6.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 1 kit/package;  (10) Medline Adult Intubation Tray, Reorder No. DYNJAA269, containing 7.0, 7.5, 8.0, and 8.5 sizes subglottic cuff, 10 kits/case. — reason: Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate.  There were also reports the suction pump is difficult to connect or detaches during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-26. Affected lots/codes: UDI-DI numbers for the individual tubes:  (1) DYNJ18860 - UDI-DI 20888277652672;  (2) DYNJ18865 - UDI-DI 20888277652689; (3) DYNJ18870 - UDI-DI 20888277652696; (4) DYNJ18875 - UDI-DI 20888277652702; (5) DYNJ18880 - UDI-DI 20888277652719; (6) DYNJ18885 - UDI-DI 20888277657318.  Kit code information:  (1) Kit ACC010502 - Kit UDI-DI: 10193489846171; Case UDI-DI: 40193489846172; lot numbers:  23FDC233, 23FDB211, 23EDC153, 23EDB775, 23DDB280, 23CDB943, 23CDA556, 22LDA029, 22IDA550, 22HDA813, 22FDC033, 22CDC284, 21JDC054, 21IDB345, 21HDB405, and 21DDB305;  (2) Kit ACC010527 - Kit UDI-DI: 10193489884333; Case UDI-DI: 40193489884334; lot numbers:  23JDA443, 23IDA363, 23IDA232, 23HDC331, 23HDA117, 23GDB600, 23FDC372, 23FDB913, 23FDA966, 23FDA310, 23EDC371, 23EDC154, 23EDC094, 23EDB732, 23EDA387, 23CDB838, 23CDA557, 23BDC008, 23BDA945, 23ADB791, 22LDA005, 22JDB800, 22HDB976, 22HDA451, 22GDB041, 21LDB937, 21LDB416, 21JDB262, 21IDB491, 21IDA193, 21GDB207, and 21FDC754;  (3) Kit ACC10540 - Kit UDI-DI: 10193489977547; Case UDI-DI 40193489977548; lot number: 23ADB410;  (4) Kit ACC10540A - Kit UDI-DI 10195327330088; Case UDI-DI 40195327330089; lot numbers: 23HDA588, 23GDB107, and 23BDA684;  (5) Kit ACC010717 - Kit UDI-DI 10195327458997; Case UDI-DI 40195327458998; lot numbers:  24ADA577, 23LDA731, and 23IDA629;  (6) Kit DYNDJ1132 - Kit UDI-DI 10195327454821; Case UDI-DI 40195327454822; lot numbers: 23LDA733, 23LDA617, 23JDC021, and  23HDA569;  (7) Kit DYNDJ1133 - Kit UDI-DI 10195327428532; Case UDI-DI 40195327428533; lot numbers: 24BMB124, 23LMB682, 23HMF259, and 23HMD765;  (8) Kit DYNJ909501 - Kit UDI-DI 10195327384852; Case UDI-DI 40195327384853; lot number:   23GBI504;  (9) Kit DYNJ909501A - Kit UDI-DI 10195327549817; Case UDI-DI 40195327549818; lot numbers: 24BBD129, 24ABK281, and 23KBR773;  (10) Kit DYNJAA269 - Kit UDI-DI 10195327209049; Case UDI-DI 40195327209040; lot numbers: 24BBE224, 24ABM718, 24ABD835, 23LBB055, 23JBP694, 23JBQ783, 23IBU821, 23IBF348, 23HBP188, 23CBX318, 23CBX319, 23BBR494, 23ABI514,22LBI988, 22KBH009, and 22JBH478.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
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        "occurred": true,
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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-1876-2024&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-1876-2024&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-1876-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1876-2024 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",
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      "epistemicStatus": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1876-2024&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-1876-2024/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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            "Value": "Z-1876-2024",
            "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 I",
            "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": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate.  There were also reports the suction pump is difficult to connect or detaches during use.",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-02-26",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI numbers for the individual tubes:  (1) DYNJ18860 - UDI-DI 20888277652672;  (2) DYNJ18865 - UDI-DI 20888277652689; (3) DYNJ18870 - UDI-DI 20888277652696; (4) DYNJ18875 - UDI-DI 20888277652702; (5) DYNJ18880 - UDI-DI 20888277652719; (6) DYNJ18885 - UDI-DI 20888277657318.  Kit code information:  (1) Kit ACC010502 - Kit UDI-DI: 10193489846171; Case UDI-DI: 40193489846172; lot numbers:  23FDC233, 23FDB211, 23EDC153, 23EDB775, 23DDB280, 23CDB943, 23CDA556, 22LDA029, 22IDA550, 22HDA813, 22FDC033, 22CDC284, 21JDC054, 21IDB345, 21HDB405, and 21DDB305;  (2) Kit ACC010527 - Kit UDI-DI: 10193489884333; Case UDI-DI: 40193489884334; lot numbers:  23JDA443, 23IDA363, 23IDA232, 23HDC331, 23HDA117, 23GDB600, 23FDC372, 23FDB913, 23FDA966, 23FDA310, 23EDC371, 23EDC154, 23EDC094, 23EDB732, 23EDA387, 23CDB838, 23CDA557, 23BDC008, 23BDA945, 23ADB791, 22LDA005, 22JDB800, 22HDB976, 22HDA451, 22GDB041, 21LDB937, 21LDB416, 21JDB262, 21IDB491, 21IDA193, 21GDB207, and 21FDC754;  (3) Kit ACC10540 - Kit UDI-DI: 10193489977547; Case UDI-DI 40193489977548; lot number: 23ADB410;  (4) Kit ACC10540A - Kit UDI-DI 10195327330088; Case UDI-DI 40195327330089; lot numbers: 23HDA588, 23GDB107, and 23BDA684;  (5) Kit ACC010717 - Kit UDI-DI 10195327458997; Case UDI-DI 40195327458998; lot numbers:  24ADA577, 23LDA731, and 23IDA629;  (6) Kit DYNDJ1132 - Kit UDI-DI 10195327454821; Case UDI-DI 40195327454822; lot numbers: 23LDA733, 23LDA617, 23JDC021, and  23HDA569;  (7) Kit DYNDJ1133 - Kit UDI-DI 10195327428532; Case UDI-DI 40195327428533; lot numbers: 24BMB124, 23LMB682, 23HMF259, and 23HMD765;  (8) Kit DYNJ909501 - Kit UDI-DI 10195327384852; Case UDI-DI 40195327384853; lot number:   23GBI504;  (9) Kit DYNJ909501A - Kit UDI-DI 10195327549817; Case UDI-DI 40195327549818; lot numbers: 24BBD129, 24ABK281, and 23KBR773;  (10) Kit DYNJAA269 - Kit UDI-DI 10195327209049; Case UDI-DI 40195327209040; lot numbers: 24BBE224, 24ABM718, 24ABD835, 23LBB055, 23JBP694, 23JBQ783, 23IBU821, 23IBF348, 23HBP188, 23CBX318, 23CBX319, 23BBR494, 23ABI514,22LBI988, 22KBH009, and 22JBH478.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution was nationwide.  There was government/military distributon.  Foreign distribution was made to San Salvador and United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}