{
  "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  10JW4A32  10HW4A29  10JW4A44  10JW4A35  10HW4A45  10JW4A05  10JW4A08  10JW4A46  10JW4A36  10JW4A30  10JW4A39  10JW4A06  10JW4A21  10JW4A01  10JW4A27  10KW4A47  10JW4A29  10JW4A41  10KW4A122  10JW4A02  10KW4A05  10JW4A25  10KW4A38  10KW4A61  10KW4A11  10KW4A16  10KW4A27  10KW4A08  10KW4A117  10KW4A68  10KW4A99  10KW4A91  10KW4A20  10KW4A53  10KW4A106  10KW4A02  10JW4A20  10KW4A35  10KW4A18  10KW4A101  10AX4A21  10JW4A43  10KW4A73  10KW4A123  10KW4A67  10AX4B27  10KW4A31  10KW4A24  10AX4A37  10KW4A83  10AX4A36  10AX4A22  10AX4A10  10KW4A42  10KW4A119  10AX4B24  10KW4A89  10KW4A71  10KW4A116  10AX4A12  10DX4A79  10DX4A10  10AX4B06  10AX4B09  10DX4A95  10AX4A81  10AX4A98  10KW4A103  10AX4A96  10AX4A95  10AX4B82  10AX4A76  10KW4A48  10HY4C42  10KW4A09  10AX4A88  10DX4A32  10AX4A87  10AX4B92  10GX4B05  10GX4A30  10KW4A104  10AX4A14  10DX4A98  10GX4B21  10AX4A85  10KW4A85  10KW4A06  10AX4A73  10GX4A21  10GX4A09  10DX4A85  10GX4A82  10JW4A31  10GX4A87  10JW4A16  10GX4A85  10KW4A12  10GX4B16  10KW4A43  10GX4A34  10GX4A83  10AX4B78  10GX4B03  10GX4A38  10GX4B08  10KW4A29  10GX4B07  10KW4A30  10GX4A32  10AX4B90  10GX4A70  10AX4B81  10AX4B53  10GX4A92  10KY4A20  10KW4A52  10KW4A39  10GX4A19  10GX4A96  10DX4A21  10KX4A02  10DX4B07  10KX4A12  10KX4A15  10KW4A75  10GX4A99  10KX4A43  10GX4A45  10KX4A40  10KX4A41  10DX4A09  10DX4A74  10DX4A48  10KX4A42  10GX4A97  10GX4A10  10AX4B80  10KX4A59  10JW4A04  10KW4A44  10GX4A73  10KX4A14  10KX4A13  10GX4B15  10KX4A70  10KX4A57  10KX4A74  10KW4A25  10GX4A03  10GX4A63  10GX4A71  10KW4A108  10KX4A85  10KW4A105  10GX4A40  10GX4A14  10DX4A33  10BY4A40  10BY4A51  10BY4A39  10KX4A62  10BY4A25  10BY4A59  10BY4A36  10EY4A53  10KX4A10  10KX4A39  10EY4A27  10KX4A26  10EY4A26  10BY4A60  10EY4A38  10KX4A80  10BY4A57  10EY4A17  10EY4A83  10EY4A03  10BY4A48  10EY4A25  10EY4A29  10EY4A88  10EY4A99  10EY4A59  10EY4A05  10EY4A82  10EY4A19  10EY4A67  10EY4A89  10BY4A52  10KX4A17  10EY4A36  10EY4A58  10EY4A73  10EY4A43  10GX4A12  10KX4A78  10EY4A15  10BY4A34  10GY4A63  10EY4A37  10EY4A98  10KX4A25  10BY4A30  10GY4A16  10EY4A48  10KX4A76  10GY4A11  10GY4A19  10GY4A60  10GY4A55  10GY4A50  10GY4A49  10GY4A54  10BY4A31  10EY4A72  10KX4A11  10GY4A66  10GY4A40  10GY4A18  10EY4A94  10GY4A32  10EY4A13  10EY4A46  10GY4A72  10GY4A20  10GY4A06  10KX4A27  10KX4A08  10GY4A45  10KX4A30  10GY4A25  10KX4A32  10BY4A42  10GY4A15  10HY4B20  10GY4A35  10GY4A12  10GY4A58  10HY4B44  10GY4A23  10HY4B29  10GY4A21  10GY4A31  10GY4A53  10HY4B18  10KX4A29  10GY4A52  10HY4B16  10HY4B42  10HY4A97  10GY4A74  10HY4B48  10GY4A34  10HY4B41  10HY4B03  10EY4A76  10GY4A26  10HY4B23  10HY4B40  10HY4B25  10HY4B37  10HY4B55  10HY4B02  10HY4A85  10HY4B22  10HY4B54  10HY4B07  10HY4B80  10HY4B26  10HY4A78  10HY4C29  10HY4C11  10GY4A52¿  10GX4B14  10KY4A41  10KX4A71  10GX4B02  10AX4B85  10HY4C03  10HY4B86  10HY4C16  10HY4C46  10HY4C34  10HY4B17  10HY4B65  10HY4B30  10HY4B62  10HY4B56  10HY4C35  10HY4B33  10HY4A81  10HY4C13  10HY4B10  10HY4C07  10HY4C27  10HY4C12  10HY4B96  10HY4B76  10HY4B24  10HY4C08  10HY4C39  10HY4C06  10HY4B83  10HY4C30  10HY4C36  10IY4A46  10HY4C40  10HY4B70  10IY4A29  10HY4C01  10HY4A98  10HY4B08  10IY4A17  10HY4C47  10HY4C32  10HY4C26  10IY4A38  10IY4A25  10HY4A80  10IY4A37  10IY4A43  10HY4C41  10IY4A51  10IY4A19  10IY4A33  10HY4B91  10HY4B51  10JY4A10  10KY4A60  10KY4A93  10KY4A15  10JY4A15  10KY4A21  10IY4A27  10IY4A13  10JY4A18  10JY4A07  10KY4A71  10KY4A39  10KY4A06  10HY4B97  10KY4A72  10KY4A86  10IY4A54  10KY4A87  10KY4A31  10AZ4A51  10KY4A25  10IY4A28  10KY4A50  10AZ4A35  10AZ4A24  10KY4A91  10AZ4A57  10IY4A31  10KY4A78  10KY4A84  10KY4A03  10KY4A82  10KY4A62  10KY4A44  10KY4A13  10HY4A79  10KY4A69  10AZ4A15  10JY4A28  10KY4A51  10JY4A16  10KY4A36  10AZ4A14  10AZ4A65  10KY4A94  10KY4A64  10KY4A47  10KY4A67  10JY4A03  10HY4A91  10AZ4A54  10HY4C23  10AZ4A08  10KY4A40  10AZ4A31  10BZ4A26  10KY4A79  10IY4A04  10EY4A60  10HY4B90  10KY4A90  10EY4A40  10KY4A30  10IY4A02  10AZ4A22",
      "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": "Prometra Programmable 20mL Pump. Catalog No. 11827 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-1120-2020",
      "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"
    }
  ]
}