{
  "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": [
    {
      "status": "Terminated",
      "city": "Mansfield",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88044",
      "recalling_firm": "Flowonix Medical Inc",
      "address_1": "120 Forbes Blvd Ste 170",
      "address_2": "N/A",
      "postal_code": "02048-1150",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1996-2021",
      "product_description": "Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following:  Prometra Programmable Infusion Pump System:   MODEL/CATALOG #(s):   Catalog No.\tUS Model \t                                                  GTIN-14    11827 \tPrometra Programmable 20mL Pump\t      00810335020082    13827 \tPrometra II Programmable 20mLPump \t00810335020228    16827\tPrometra II Programmable 40mLPump\t00810335020242",
      "product_quantity": "N/A",
      "reason_for_recall": "Physician Order Form (PL-15400-00 Nov 2018)    distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection",
      "recall_initiation_date": "20210526",
      "center_classification_date": "20210701",
      "termination_date": "20240220",
      "report_date": "20210707",
      "code_info": "All Physician Order Form (PL-15400-00, Nov. 2018)"
    }
  ]
}