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  "name": "Brand Name: Celsior Cold Storage Solution  Product Name: Celsior Cold Storage Solution  Model/Catalog Number: 533682  Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for  hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in  preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in  one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).",
  "description": "FDA recall Z-2220-2025 — INSTITUT GEORGES LOPEZ is recalling Brand Name: Celsior Cold Storage Solution  Product Name: Celsior Cold Storage Solution  Model/Catalog Number: 533682  Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for  hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in  preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in  one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas). (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": "openFDA drug & device enforcement (recall) reports",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Celsior Cold Storage Solution  Product Name: Celsior Cold Storage Solution  Model/Catalog Number: 533682  Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for  hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in  preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in  one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).",
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      "name": "INSTITUT GEORGES LOPEZ"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2220-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2220-2025: INSTITUT GEORGES LOPEZ is recalling Brand Name: Celsior Cold Storage Solution  Product Name: Celsior Cold Storage Solution  Model/Catalog Number: 533682  Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for  hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in  preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in  one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).",
      "text": "The FDA logged enforcement record Z-2220-2025: INSTITUT GEORGES LOPEZ is voluntarily recalling Brand Name: Celsior Cold Storage Solution  Product Name: Celsior Cold Storage Solution  Model/Catalog Number: 533682  Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for  hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in  preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in  one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F.  In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas). — reason: The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-13. Affected lots/codes: Lot Code: UDI carton box: 23700911900123 & UDI bag: 13700911900126 (for US reference). The product reference recalled in France is different and there is no UDI on this one (not required for medicine in France). Batches concerned by the recall are the following: Lot SL240261-1 Lot SL240266-1 Lot SL240272-1 Lot SL240280-2 These batches have been sold only in France. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2220-2025 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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      "@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": "Lot Code: UDI carton box: 23700911900123 & UDI bag: 13700911900126 (for US reference). The product reference recalled in France is different and there is no UDI on this one (not required for medicine in France). Batches concerned by the recall are the following: Lot SL240261-1 Lot SL240266-1 Lot SL240272-1 Lot SL240280-2 These batches have been sold only in France",
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