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  "name": "Atrium Pneumostat Chest Drain Valve, Part Number 16100",
  "description": "FDA recall Z-1302-2023 — Atrium Medical Corporation is recalling Atrium Pneumostat Chest Drain Valve, Part Number 16100 (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": "FDA recall Z-1302-2023: Atrium Medical Corporation is recalling Atrium Pneumostat Chest Drain Valve, Part Number 16100",
      "text": "The FDA logged enforcement record Z-1302-2023: Atrium Medical Corporation is voluntarily recalling Atrium Pneumostat Chest Drain Valve, Part Number 16100 — reason: The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-03-01. Affected lots/codes: UDI-DI: 20650862161001;  All lots manufactured 3 years prior to correction initiation:  Lot Numbers: 453404 455900 458299 464069 455901 454344     448618 449703 449992 449993 450923 450924 451439 452012 452013 452575 453404 453472 454260 454344 454345 454589 454803 454850 454851 455359 455360 455370 455898 455900 455901 456447 456448 456904 456905 458298 458299 458300 458301 458642 458643 458644 458645 461545 463439 463441 463442 463443 463469 463586 463587 464069 464103 464104 464105 464669 464809 465368. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1302-2023 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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      "@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": "The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.",
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