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  "name": "STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.    Model/Catalog Number: SL-2000M2095DA",
  "description": "FDA recall Z-3175-2024 — B Braun Medical Inc is recalling STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.    Model/Catalog Number: SL-2000M2095DA (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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    "name": "STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.    Model/Catalog Number: SL-2000M2095DA",
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      "name": "FDA recall Z-3175-2024: B Braun Medical Inc is recalling STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.    Model/Catalog Number: SL-2000M2095DA",
      "text": "The FDA logged enforcement record Z-3175-2024: B Braun Medical Inc is voluntarily recalling STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis.    Model/Catalog Number: SL-2000M2095DA — reason: Incomplete insertion of the patient connector of the  Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-15. Affected lots/codes: UDI-DI 04046955776023;  All Unexpired Lot Numbers. A RECORDED FDA enforcement action (occurred=true).",
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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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-3175-2024 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.",
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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."
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      "@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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      "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": "Incomplete insertion of the patient connector of the  Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method",
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