{ "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": "809", "code_info": "Serial Numbers: 10AX4A03 10BY4A40 10EY4A35 10GX4A83 10HW4A31 10HY4C11 10JW4A28 10KW4A42 10KX4A48 10AX4A04 10BY4A41 10EY4A36 10GX4A84 10HW4A45 10HY4C12 10JW4A29 10KW4A43 10KX4A49 10AX4A06 10BY4A42 10EY4A37 10GX4A85 10HW4A57 10HY4C13 10JW4A30 10KW4A44 10KX4A50 10AX4A10 10BY4A44 10EY4A38 10GX4A86 10HY4A77 10HY4C15 10JW4A31 10KW4A45 10KX4A52 10AX4A12 10BY4A45 10EY4A40 10GX4A87 10HY4A78 10HY4C16 10JW4A32 10KW4A46 10KX4A56 10AX4A14 10BY4A46 10EY4A41 10GX4A88 10HY4A79 10HY4C17 10JW4A33 10KW4A47 10KX4A57 10AX4A21 10BY4A47 10EY4A43 10GX4A89 10HY4A80 10HY4C18 10JW4A34 10KW4A48 10KX4A58 10AX4A22 10BY4A48 10EY4A44 10GX4A92 10HY4A81 10HY4C19 10JW4A35 10KW4A49 10KX4A59 10AX4A23 10BY4A49 10EY4A45 10GX4A94 10HY4A82 10HY4C20 10JW4A36 10KW4A50 10KX4A60 10AX4A28 10BY4A50 10EY4A46 10GX4A96 10HY4A83 10HY4C22 10JW4A37 10KW4A51 10KX4A62 10AX4A30 10BY4A51 10EY4A47 10GX4A97 10HY4A84 10HY4C23 10JW4A38 10KW4A52 10KX4A63 10AX4A36 10BY4A52 10EY4A48 10GX4A98 10HY4A85 10HY4C26 10JW4A39 10KW4A53 10KX4A64 10AX4A37 10BY4A53 10EY4A51 10GX4A99 10HY4A87 10HY4C27 10JW4A40 10KW4A54 10KX4A65 10AX4A39 10BY4A54 10EY4A52 10GX4B02 10HY4A90 10HY4C28 10JW4A41 10KW4A55 10KX4A66 10AX4A42 10BY4A55 10EY4A53 10GX4B03 10HY4A91 10HY4C29 10JW4A42 10KW4A56 10KX4A67 10AX4A48 10BY4A56 10EY4A54 10GX4B04 10HY4A92 10HY4C30 10JW4A43 10KW4A57 10KX4A68 10AX4A51 10BY4A57 10EY4A55 10GX4B05 10HY4A95 10HY4C32 10JW4A44 10KW4A58 10KX4A69 10AX4A73 10BY4A58 10EY4A56 10GX4B06 10HY4A97 10HY4C34 10JW4A45 10KW4A59 10KX4A70 10AX4A74 10BY4A59 10EY4A58 10GX4B07 10HY4A98 10HY4C35 10JW4A46 10KW4A60 10KX4A71 10AX4A76 10BY4A60 10EY4A59 10GX4B08 10HY4B01 10HY4C36 10JW4A47 10KW4A61 10KX4A72 10AX4A81 10BZ4A24 10EY4A60 10GX4B09 10HY4B02 10HY4C37 10JW4A48 10KW4A63 10KX4A73 10AX4A83 10BZ4A26 10EY4A61 10GX4B10 10HY4B03 10HY4C39 10JY4A01 10KW4A64 10KX4A74 10AX4A85 10BZ4A32 10EY4A62 10GX4B11 10HY4B05 10HY4C40 10JY4A03 10KW4A65 10KX4A76 10AX4A87 10BZ4A46 10EY4A63 10GX4B12 10HY4B07 10HY4C41 10JY4A06 10KW4A66 10KX4A77 10AX4A88 10BZ4A70 10EY4A64 10GX4B13 10HY4B08 10HY4C42 10JY4A07 10KW4A67 10KX4A78 10AX4A89 10BZ4A71 10EY4A65 10GX4B14 10HY4B10 10HY4C46 10JY4A09 10KW4A68 10KX4A79 10AX4A93 10CZ4A02 10EY4A66 10GX4B15 10HY4B12 10HY4C47 10JY4A10 10KW4A70 10KX4A80 10AX4A95 10CZ4A03 10EY4A67 10GX4B16 10HY4B16 10IY2A05 10JY4A15 10KW4A71 10KX4A81 10AX4A96 10CZ4A04 10EY4A69 10GX4B21 10HY4B17 10IY2A26 10JY4A16 10KW4A72 10KX4A82 10AX4A98 10DX4A03 10EY4A70 10GX4B22 10HY4B18 10IY4A01 10JY4A18 10KW4A73 10KX4A85 10AX4B06 10DX4A07 10EY4A72 10GX4B25 10HY4B19 10IY4A02 10JY4A20 10KW4A74 10KY4A02 10AX4B08 10DX4A09 10EY4A73 10GY4A02 10HY4B20 10IY4A03 10JY4A21 10KW4A75 10KY4A03 10AX4B09 10DX4A10 10EY4A74 10GY4A03 10HY4B22 10IY4A04 10JY4A25 10KW4A76 10KY4A04 10AX4B16 10DX4A13 10EY4A75 10GY4A05 10HY4B23 10IY4A05 10JY4A28 10KW4A77 10KY4A06 10AX4B17 10DX4A21 10EY4A76 10GY4A06 10HY4B24 10IY4A09 10JY4A29 10KW4A78 10KY4A07 10DX4A24 10EY4A81 10GY4A11 10HY4B26 10IY4A11 10KV4A01 10KW4A80 10KY4A10 10AX4B26 10DX4A32 10EY4A82 10GY4A12 10HY4B27 10IY4A13 10KW4A01 10KW4A81 10KY4A11 10AX4B27 10DX4A33 10EY4A83 10GY4A13 10HY4B28 10IY4A15 10KW4A02 10KW4A83 10KY4A12 10AX4B29 10DX4A34 10EY4A87 10GY4A14 10HY4B29 10IY4A17 10KW4A03 10KW4A84 10KY4A13 10AX4B53 10DX4A41 10EY4A88 10GY4A15 10HY4B30 10IY4A19 10KW4A04 10KW4A85 10KY4A15 10AX4B78 10DX4A44 10EY4A89 10GY4A16 10HY4B33 10IY4A25 10KW4A05 10KW4A86 10KY4A17 10AX4B79 10DX4A48 10EY4A90 10GY4A18 10HY4B34 10IY4A26 10KW4A06 10KW4A87 10KY4A18 10AX4B80 10DX4A52 10EY4A92 10GY4A19 10HY4B35 10IY4A27 10KW4A07 10KW4A88 10KY4A20 10AX4B81 10DX4A60 10EY4A93 10GY4A20 10HY4B36 10IY4A28 10KW4A08 10KW4A89 10KY4A21 10AX4B82 10DX4A62 10EY4A94 10GY4A21 10HY4B37 10IY4A29 10KW4A09 10KW4A90 10KY4A25 10AX4B84 10DX4A65 10EY4A95 10GY4A22 10HY4B40 10IY4A31 10KW4A10 10KW4A91 10KY4A26 10AX4B85 10DX4A67 10EY4A96 10GY4A23 10HY4B41 10IY4A33 10KW4A101 10KW4A92 10KY4A27 10AX4B86 10DX4A71 10EY4A97 10GY4A25 10HY4B42 10IY4A37 10KW4A103 10KW4A93 10KY4A30 10AX4B88 10DX4A74 10EY4A98 10GY4A26 10HY4B43 10IY4A38 10KW4A104 10KW4A94 10KY4A31 10AX4B90 10DX4A79 10EY4A99 10GY4A27 10HY4B44 10IY4A41 10KW4A105 10KW4A95 10KY4A33 10AX4B91 10DX4A82 10GX4A03 10GY4A28 10HY4B45 10IY4A43 10KW4A106 10KW4A96 10KY4A35 10AX4B92 10DX4A85 10GX4A04 10GY4A30 10HY4B48 10IY4A44 10KW4A108 10KW4A98 10KY4A36 10AX4B94 10DX4A89 10GX4A08 10GY4A31 10HY4B49 10IY4A46 10KW4A109 10KW4A99 10KY4A37 10AX4B96 10DX4A95 10GX4A09 10GY4A32 10HY4B50 10IY4A50 10KW4A11 10KX4A01 10KY4A39 10AX4B97 10DX4A96 10GX4A10 10GY4A34 10HY4B51 10IY4A51 10KW4A110 10KX4A02 10KY4A40 10AZ4A08 10DX4A98 10GX4A12 10GY4A35 10HY4B53 10IY4A52 10KW4A111 10KX4A04 10KY4A41 10AZ4A10 10DX4A99 10GX4A14 10GY4A36 10HY4B54 10IY4A54 10KW4A113 10KX4A05 10KY4A43 10AZ4A12 10DX4B02 10GX4A15 10GY4A39 10HY4B55 10IY4A56 10KW4A116 10KX4A06 10KY4A44 10AZ4A14 10DX4B03 10GX4A16 10GY4A40 10HY4B56 10IY4A58 10KW4A117 10KX4A07 10KY4A45 10AZ4A15 10DX4B07 10GX4A19 10GY4A41 10HY4B62 10IY4A59 10KW4A119 10KX4A08 10KY4A47 10AZ4A18 10DX4B15 10GX4A21 10GY4A42 10HY4B63 10IY4A60 10KW4A12 10KX4A09 10KY4A50 10AZ4A19 10DX4B17 10GX4A30 10GY4A44 10HY4B65 10IY4A61 10KW4A120 10KX4A10 10KY4A51 10AZ4A22 10DX4B21 10GX4A31 10GY4A45 10HY4B66 10IY4A62 10KW4A121 10KX4A11 10KY4A60 10AZ4A24 10DX4B25 10GX4A32 10GY4A47 10HY4B69 10JW4A01 10KW4A122 10KX4A12 10KY4A61 10AZ4A31 10DX4B26 10GX4A33 10GY4A49 10HY4B70 10JW4A02 10KW4A123 10KX4A13 10KY4A62 10AZ4A33 10EY4A01 10GX4A34 10GY4A50 10HY4B74 10JW4A03 10KW4A125 10KX4A14 10KY4A63 10AZ4A43 10EY4A02 10GX4A37 10GY4A51 10HY4B76 10JW4A04 10KW4A13 10KX4A15 10KY4A64 10AZ4A54 10EY4A03 10GX4A38 10GY4A52 10HY4B78 10JW4A05 10KW4A14 10KX4A16 10KY4A65 10AZ4A57 10EY4A04 10GX4A39 10GY4A53 10HY4B79 10JW4A06 10KW4A15 10KX4A17 10KY4A67 10AZ4A59 10EY4A05 10GX4A40 10GY4A54 10HY4B80 10JW4A07 10KW4A16 10KX4A18 10KY4A68 10AZ4A61 10EY4A08 10GX4A44 10GY4A55 10HY4B81 10JW4A08 10KW4A17 10KX4A19 10KY4A69 10AZ4A65 10EY4A11 10GX4A45 10GY4A56 10HY4B83 10JW4A09 10KW4A18 10KX4A20 10KY4A71 10AZ4A70 10EY4A13 10GX4A46 10GY4A57 10HY4B84 10JW4A10 10KW4A19 10KX4A21 10KY4A72 10AZ4A73 10EY4A14 10GX4A47 10GY4A58 10HY4B85 10JW4A11 10KW4A20 10KX4A22 10KY4A75 10BY4A25 10EY4A15 10GX4A48 10GY4A59 10HY4B86 10JW4A12 10KW4A21 10KX4A25 10KY4A78 10BY4A26 10EY4A16 10GX4A57 10GY4A60 10HY4B90 10JW4A13 10KW4A23 10KX4A26 10KY4A79 10BY4A27 10EY4A17 10GX4A62 10GY4A61 10HY4B91 10JW4A14 10KW4A24 10KX4A27 10KY4A82 10GX4A65 10GY4A63 10HY4B96 10JW4A16 10KW4A26 10KX4A29 10KY4A84 10BY4A30 10EY4A21 10GX4A67 10GY4A64 10HY4B97 10JW4A17 10KW4A27 10KX4A30 10KY4A86 10BY4A31 10EY4A22 10GX4A69 10GY4A65 10HY4B99 10JW4A18 10KW4A29 10KX4A32 10KY4A87 10BY4A32 10EY4A24 10GX4A70 10GY4A66 10HY4C01 10JW4A19 10KW4A30 10KX4A39 10KY4A90 10BY4A33 10EY4A25 10GX4A71 10GY4A67 10HY4C02 10JW4A20 10KW4A31 10KX4A40 10KY4A91 10BY4A34 10EY4A26 10GX4A72 10GY4A70 10HY4C03 10JW4A21 10KW4A32 10KX4A41 10KY4A92 10BY4A35 10EY4A27 10GX4A73 10GY4A71 10HY4C04 10JW4A22 10KW4A35 10KX4A42 10KY4A93 10BY4A36 10EY4A28 10GX4A74 10GY4A72 10HY4C06 10JW4A24 10KW4A38 10KX4A43 10KY4A94 10BY4A37 10EY4A29 10GX4A76 10GY4A73 10HY4C07 10JW4A25 10KW4A39 10KX4A44 10KY4A97 10BY4A38 10EY4A31 10GX4A81 10GY4A74 10HY4C08 10JW4A26 10KW4A40 10KX4A46 10KY4A99 10BY4A39 10EY4A33 10GX4A82 10HW4A29 10HY4C09 10JW4A27 10KW4A41 10KX4A47", "center_classification_date": "20190603", "distribution_pattern": "US nationwide distribution.", "state": "MA", "product_description": "Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.", "report_date": "20190612", "classification": "Class II", "openfda": {}, "recalling_firm": "Flowonix Medical Inc", "recall_number": "Z-1714-2019", "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" } ] }