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  "name": "Brand Name: FEM-FLEX II  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018A  Software Version: N/A  Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
  "description": "FDA recall Z-2084-2025 — Edwards Lifesciences, LLC is recalling Brand Name: FEM-FLEX II  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018A  Software Version: N/A  Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No (Devices, Class I). 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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "Brand Name: FEM-FLEX II  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018A  Software Version: N/A  Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
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      "name": "Edwards Lifesciences, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2084-2025/enforcement-record",
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      "name": "FDA recall Z-2084-2025: Edwards Lifesciences, LLC is recalling Brand Name: FEM-FLEX II  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018A  Software Version: N/A  Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No",
      "text": "The FDA logged enforcement record Z-2084-2025: Edwards Lifesciences, LLC is voluntarily recalling Brand Name: FEM-FLEX II  Product Name: Femoral Arterial Cannula  Model/Catalog Number: FEMII018A  Software Version: N/A  Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.  Component: No — reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-14. Affected lots/codes: Lot Code: Model No: FEMII018A; UDI: 0069013031256; All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2084-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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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-2084-2025 as Class I",
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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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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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": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-05-14",
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            "Value": "Lot Code: Model No: FEMII018A; UDI: 0069013031256; All lots up to: BSLC9148 Serial Numbers: 130468 130599 130704 130848 130953 131048 131286 131430 131626 131774 131775 132004 132005 132510 BSLC0025 BSLC0121 BSLC0422 BSLC1115 BSLC1470 BSLC4161 BSLC4472 BSLC5041 BSLC5293 BSLC5842 BSLC6163 BSLC6164 BSLC7336 BSLC7794 BSLC8660 BSLC9148",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA,  ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA,  FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY,  LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI,  MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO,  NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece,  Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta,  Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania,  Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan,  Thailand, United Arab Emirates (UAE), United Kingdom.",
            "Status": "recorded"
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