{
  "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  10HW4A57  10AX4A06  36ES4A15  36AR4A04  36AR4A06  36AR4A13  36HS4A10  36HS4A54  36JN4A04  36JN4A06  36JN4A07  36JN4A09  36JN4A13  36JN4A14  36JN4A15  36JN4A18  36JN4A23  36JN4A28  36JN4A35  36KN4A11  36KN4A16  36KN4A23  36KN4A27  36KN4A33  36KN4A34  36KN4A41  36HS4A01  10IT4A21  36HS4A14  36HS4A26  36BS4A17  36ES4A28  36ES4A33  36ES4A08  10IT4A16  36FR4A13  36HS4A61  10ET4A07  36HS4A46  10ET4A20  36HS4A25  36HS4A43  10ET4A02",
      "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": "US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082",
      "report_date": "20200219",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Flowonix Medical Inc",
      "recall_number": "Z-1123-2020",
      "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"
    }
  ]
}