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  "name": "0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10",
  "description": "FDA recall D-0347-2023 — B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10 (Drugs, 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": "0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10",
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      "name": "B. Braun Medical Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0347-2023/enforcement-record",
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      "name": "FDA recall D-0347-2023: B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10",
      "text": "The FDA logged enforcement record D-0347-2023: B. Braun Medical Inc. is voluntarily recalling 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10 — reason: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage.  The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2023-02-10. Affected lots/codes: Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024. A RECORDED FDA enforcement action (occurred=true).",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": 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=D-0347-2023&lang=eng",
        "value": "Drugs recall, status Completed",
        "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=D-0347-2023&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/D-0347-2023/fda-classification",
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      "name": "FDA classified recall D-0347-2023 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.",
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        "value": "Class II",
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          "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/D-0347-2023/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.",
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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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            "Value": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
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            "Field": "Recalling firm",
            "Value": "B. Braun Medical Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage.  The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.",
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            "Field": "Initiated",
            "Value": "2023-02-10",
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          "position": 11,
          "item": {
            "Field": "Distribution pattern",
            "Value": "USA Nationwide.",
            "Status": "recorded"
          }
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}