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  "name": "Brand Name: Fortress Introducer Sheath System  Product Name: Fortress Introducer Sheath System  Model/Catalog Number: 386594  Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:",
  "description": "FDA recall Z-2532-2025 — Contract Medical International GmbH is recalling Brand Name: Fortress Introducer Sheath System  Product Name: Fortress Introducer Sheath System  Model/Catalog Number: 386594  Product Description: Fortress Introducer Sheath System, 6F Straight 45cm: (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-2532-2025: Contract Medical International GmbH is recalling Brand Name: Fortress Introducer Sheath System  Product Name: Fortress Introducer Sheath System  Model/Catalog Number: 386594  Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:",
      "text": "The FDA logged enforcement record Z-2532-2025: Contract Medical International GmbH is voluntarily recalling Brand Name: Fortress Introducer Sheath System  Product Name: Fortress Introducer Sheath System  Model/Catalog Number: 386594  Product Description: Fortress Introducer Sheath System, 6F Straight 45cm: — reason: Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-07-30. Affected lots/codes: Lot Code: Model Number: 386594 Lot Number: 800989 Unique Device Identifier: 04251244503703 Expiration Date: 31 OCT 2027.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2532-2025 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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      "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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