{
  "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": "318",
      "code_info": "Serial Numbers:     A15E0017  A15J0019  A16D0004  RA17B0003  RA17I0001  RA18B0008  RA18D0046  RA18G0074  RA18J0074  A15E0023  A15J0035  A16D0013  RA17B0004  RA17I0002  RA18B0009  RA18D0047  RA18G0079  RA18J0077  A15E0032  A15J0038  A16D0015  RA17B0007  RA17I0003  RA18B0012  RA18D0048  RA18G0080  RA18J0078  A15H0003  A15J0047  A16D0018  RA17C0001  RA17I0004  RA18B0014  RA18D0052  RA18J0001  RA18J0081  A15H0007  A15J0050  A16D0026  RA17C0005  RA17I0005  RA18B0016  RA18D0053  RA18J0002  RA18J050  A15H0031  A15J0051  A16D0032  RA17C0006  RA17I0007  RA18B0018  RA18G0004  RA18J0003  RA18K0003  A15H0038  A15K0018  A16D0033  RA17C0007  RA17I0008  RA18B0020  RA18G0005  RA18J0004  RA18K0004  A15H0039  A15K0036  A16D0036  RA17C0025  RA17I0010  RA18B0023  RA18G0006  RA18J0009  RA18K0007  A15H0054  A15K0042  A16D0037  RA17C0028  RA17I0012  RA18B0026  RA18G0007  RA18J0011  RA18K0008  A15H0067  A15K0045  A16D0039  RA17C0038  RA17I0021  RA18B0027  RA18G0010  RA18J0012  RA18K001  A15I0005  A15K0046  A16D0040  RA17C0039  RA17I0024  RA18B0030  RA18G0011  RA18J0013  RA18K0010  A15I0015  A15K0053  A16D0042  RA17C0041  RA17J0003  RA18B0033  RA18G0012  RA18J0014  RA18L0001  A15I0019  A15K0055  A16D0046  RA17F0006  RA17J0004  RA18B0036  RA18G0017  RA18J0015  RA18L0002  A15I0020  A15L0003  A16D0047  RA17F0007  RA17J0005  RA18B0037  RA18G0021  RA18J0016  RA18L0004  A15I0039  A15L0029  A16D0049  RA17F0008  RA17J0008  RA18B0040  RA18G0022  RA18J0019  RA18L0007  A15I0043  A15L0067  A16D0051  RA17F0009  RA17J0011  RA18B0042  RA18G0023  RA18J0021  RA18L0010  A15I0046  A15L0068  A16D0058  RA17F0011  RA17J0016  RA18B0047  RA18G0025  RA18J0022  RA18L019  A15I0049  A15L0069  A16D0073  RA17F0012  RA17K0002  RA18B0053  RA18G0026  RA18J0023  RA18L020  A15I0058  A15L0070  A16D0074  RA17F0018  RA17K0008  RA18B0055  RA18G0027  RA18J0025  RA18L021  A15I0062  A16B0002  A17C0011  RA17F0024  RA17K0009  RA18C0003  RA18G0031  RA18J0030  RA18L022  A15I0067  A16B0003  A17D0009  RA17F0025  RA17L0001  RA18D0002  RA18G0032  RA18J0031  RA18L023  A15I0068  A16B0008  A17D0010  RA17F0028  RA17L0002  RA18D0003  RA18G0033  RA18J0034  RA18L024  A15I0070  A16C0006  A17E0003  RA17F0030  RA17L0003  RA18D0006  RA18G0040  RA18J0038  RA18L027  A15I0072  A16C0011  A17E0008  RA17F0032  RA17L0004  RA18D0007  RA18G0042  RA18J0039  RA18L028  A15I0073  A16C0012  A17E0009  RA17F0033  RA17L0008  RA18D0010  RA18G0043  RA18J0040  RA18L029  A15I0075  A16C0017  A17F0001  RA17F0037  RA17L0009  RA18D0022  RA18G0044  RA18J0041  RA18L030  A15I0089  A16C0024  A17F0003  RA17F0038  RA17L0010  RA18D0024  RA18G0045  RA18J0046  RA18L031  A15I0139  A16C0028  A17F0004  RA17F0039  RA17L0012  RA18D0026  RA18G0050  RA18J0048  RA18L032  A15I0140  A16C0030  A17F0005  RA17F0041  RA17L0014  RA18D0028  RA18G0055  RA18J0053  RA18L033  A15J0002  A16C0038  RA17A0002  RA17F0042  RA17L0022  RA18D0033  RA18G0056  RA18J0063  RA18L034  A15J0004  A16C0041  RA17A0004  RA17F0043  RA18B0001  RA18D0039  RA18G0058  RA18J0064  RA18L036  A15J0006  A16C0044  RA17A0005  RA17G0005  RA18B0002  RA18D0040  RA18G0062  RA18J0068  RA18L051  A15J0010  A16C0060  RA17A0011  RA17G0006  RA18B0004  RA18D0041  RA18G0064  RA18J0070  RA18L052  A15J0011  A16C0063  RA17A0035  RA17G0016  RA18B0006  RA18D0043  RA18G0065  RA18J0071  RA18L053  A15J0017  A16C0072  RA17A0041  RA17G0017  RA18B0007  RA18D0045  RA18G0068  RA18J0073  RA18L054  RA18L057  RA18L055  RA18L056",
      "center_classification_date": "20190603",
      "distribution_pattern": "US nationwide distribution.",
      "state": "MA",
      "product_description": "Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, 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-1712-2019",
      "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"
    }
  ]
}