{
  "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": "The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered.  There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.  Error 115 can also occur if dendrites form or if the pump is dropped.",
      "address_2": "",
      "product_quantity": "163",
      "code_info": "Serial Numbers:    10ET4A02  36AR4A11  36AR4A33  36FR4A01  36HS4A25  36JN4A09  36JN4A30  36KN4A13  36KN4A33  10ET4A06  36AR4A12  36AR4A34  36FR4A08  36HS4A26  36JN4A10  36JN4A31  36KN4A15  36KN4A34  10ET4A07  36AR4A13  36AR4A35  36FR4A09  36HS4A27  36JN4A11  36JN4A32  36KN4A16  36KN4A35  10ET4A20  36AR4A14  36AR4A37  36FR4A12  36HS4A29  36JN4A12  36JN4A33  36KN4A17  36KN4A36  10ET4A21  36AR4A15  36BS4A08  36FR4A13  36HS4A34  36JN4A13  36JN4A35  36KN4A18  36KN4A38  10ET4A46  36AR4A16  36BS4A17  36FR4A16  36HS4A39  36JN4A14  36JN4A37  36KN4A19  36KN4A40  10IT4A16  36AR4A17  36BS4A18  36FR4A19  36HS4A42  36JN4A15  36JN4A39  36KN4A20  36KN4A41  10IT4A21  36AR4A18  36ES4A03  36FR4A22  36HS4A43  36JN4A16  36KN4A01  36KN4A21  36KN4A42  10IT4A22  36AR4A19  36ES4A07  36FR4A24  36HS4A46  36JN4A17  36KN4A02  36KN4A22  36KN4A43  36AR4A01  36AR4A20  36ES4A08  36HS4A01  36HS4A51  36JN4A18  36KN4A03  36KN4A23  36KN4A44  36AR4A02  36AR4A21  36ES4A14  36HS4A02  36HS4A53  36JN4A19  36KN4A04  36KN4A24  36KN4A45  36AR4A03  36AR4A22  36ES4A15  36HS4A04  36HS4A54  36JN4A21  36KN4A05  36KN4A25  36AR4A04  36AR4A23  36ES4A17  36HS4A07  36HS4A55  36JN4A22  36KN4A06  36KN4A26  36AR4A05  36AR4A24  36ES4A18  36HS4A10  36HS4A61  36JN4A23  36KN4A07  36KN4A27  36AR4A06  36AR4A27  36ES4A19  36HS4A14  36JN4A03  36JN4A25  36KN4A08  36KN4A28  36AR4A07  36AR4A29  36ES4A20  36HS4A20  36JN4A04  36JN4A26  36KN4A09  36KN4A29  36AR4A08  36AR4A30  36ES4A22  36HS4A21  36JN4A06  36JN4A27  36KN4A10  36KN4A30  36AR4A09  36AR4A31  36ES4A28  36HS4A22  36JN4A07  36JN4A28  36KN4A11  36KN4A31  36AR4A10  36AR4A32  36ES4A33  36HS4A23  36JN4A08  36JN4A29  36KN4A12  36KN4A32",
      "center_classification_date": "20190603",
      "distribution_pattern": "US nationwide distribution.",
      "state": "MA",
      "product_description": "Prometra II Programmable Pump (Clinical), Cat. No. 01827   For intrathecal infusion.",
      "report_date": "20190612",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Flowonix Medical Inc",
      "recall_number": "Z-1716-2019",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "82586",
      "termination_date": "20200605",
      "more_code_info": "",
      "recall_initiation_date": "20190321",
      "postal_code": "02048-1150",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}