{
  "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.",
      "address_2": "",
      "product_quantity": "40",
      "code_info": "Software v.2.00.29  Serial numbers:  D18L0003  D18L0022  D18L0013  D18L0035  D18L0004  D18L0025  D18L0014  D18L0036  D18L0006  D18L0026  D18L0015  D18L0037  D18L0010  D18L0027  D18L0016  D18L0038  D18L0009  D18L0028  D18L0017  D18L0034  D18L0008  D18L0029  D18L0018  D18L0039  D18L0007  D18L0030  D18L0019  D18L0040  D18L0011  D18L0031  D18L0021  D18L0041  D18L0005  D18L0032  D18L0023  D18L0042  D18L0012  D18L0033  D18L0024  D18L0020",
      "center_classification_date": "20190603",
      "distribution_pattern": "US nationwide distribution.",
      "state": "MA",
      "product_description": "Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps.   For intrathecal infusion.",
      "report_date": "20190612",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Flowonix Medical Inc",
      "recall_number": "Z-1713-2019",
      "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"
    }
  ]
}