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  "name": "Express Mini 500 Dry Seal Chest Drain, Part Number 16400",
  "description": "FDA recall Z-1303-2023 — Atrium Medical Corporation is recalling Express Mini 500 Dry Seal Chest Drain, Part Number 16400 (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-1303-2023: Atrium Medical Corporation is recalling Express Mini 500 Dry Seal Chest Drain, Part Number 16400",
      "text": "The FDA logged enforcement record Z-1303-2023: Atrium Medical Corporation is voluntarily recalling Express Mini 500 Dry Seal Chest Drain, Part Number 16400 — 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: 00650862164008;  All lots manufactured 3 years prior to correction initiation:  Lot Numbers: 477059     478375     481999     483536     484044     485782     486195     477059     478375     481105     485782     449700 450921 451436 460632 463584 463585 464668 472965 472969 473749 477059 445024 448992 449700 449990 450921 450922 451436 452010 452011 452574 453402 460620 460621 460629 460630 460631 460632 460633 460787 461043 461333 461336 461337 461821 461822 461823 461824 461940 462215 462487 462489 463584 463585 464101 464102 464667 464668 465132 465138 465516 465517 465667 465668 472838 472965 472966 472969 473749 475492 477059 477985 475492     477059     478375     481105     481998     482573     485782     486195     486195     474692     475492     477059     478375     480643     481104     481105     481998     481999     482001     482572     482573     483028     483536     484044     485782     486195     487568     487569     487570     488316     489338     489879     489880     490140     486195     487570     490140     472838 472965 472966 472968 472969 473221 473749 474692 475491 475492 477059 477926 477983 477984 477985 478374 479256 479870 480216 480217 480641 480642 480643. A RECORDED FDA enforcement action (occurred=true).",
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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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      "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": "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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