{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Mansfield",
      "address_1": "120 Forbes Blvd Ste 170",
      "reason_for_recall": "A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain \"out of tolerance\" conditions associated with the pump's valve system.",
      "address_2": "",
      "product_quantity": "6670 (US)",
      "code_info": "All units with pump firmware version 0.26 manufactured from 2012 until the present time.    Serial Numbers  10GC4A24X  10GC4A02X  10GC4A18X  10GC4A22X  10GC4A14X  4MA00044X  4MA00006X  10GC4A12X  10GC4A09X  10GC4A06X  10GC4A21X  4MA00008X  10GC4A01X  10GC4A20X  10GC4A11X  10GC4A16X  10GC4A17X  4MA00045X  4MA00055X  10GC4A08X  4MA00032X  4MA00031X  4MA00010X  4MA00042X",
      "center_classification_date": "20200210",
      "distribution_pattern": "Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.",
      "state": "MA",
      "product_description": "Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Flowonix Medical Inc",
      "recall_number": "Z-1122-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84653",
      "more_code_info": "",
      "recall_initiation_date": "20191224",
      "postal_code": "02048-1150",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}