{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Mirandola",
      "state": "",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99462",
      "recalling_firm": "SPECTRUM MEDICAL SRL",
      "address_1": "Via Di Mezzo 23",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, KS MA, MD, MI, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WI.",
      "recall_number": "Z-3327-2026",
      "product_description": "Brand Name: Quantum PureFlow  Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W  Model/Catalog Number: HX55V-S0W  Software Version: N/A  Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min.    Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF).  Component: N/A",
      "product_quantity": "9448",
      "reason_for_recall": "Due to blood-to-glycol leak in the heat exchanger.",
      "recall_initiation_date": "20260717",
      "center_classification_date": "20260929",
      "report_date": "20261007",
      "code_info": "Lot Code: 18051160302205 (HX55V-S0W)",
      "more_code_info": ""
    }
  ]
}