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  "name": "Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU",
  "description": "FDA recall Z-0318-2024 — Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU (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": "Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU",
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      "name": "FDA recall Z-0318-2024: Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU",
      "text": "The FDA logged enforcement record Z-0318-2024: Atrium Medical Corporation is voluntarily recalling Express Dry Seal Chest Drains (Express):    4000-100N DRAIN, EXPRESS, SINGLE;  4050-100N DRAIN, EXPRESS, BRU — reason: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of  catheter(s) and patient tube connections with single collection chamber chest drains. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-18. Affected lots/codes: UDI-DI:  (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141  All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020. 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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."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-0318-2024 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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      "@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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            "Field": "Reason",
            "Value": "Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of  catheter(s) and patient tube connections with single collection chamber chest drains",
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            "Field": "Initiated",
            "Value": "2023-09-18",
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            "Value": "UDI-DI:  (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141  All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020",
            "Status": "recorded"
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            "Status": "recorded"
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