FDA Device recall Z-1120-2020
Prometra Programmable 20mL Pump
- FDA Device
- Class II
- ongoing
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Prometra Programmable 20mL Pump by Flowonix Medical, citing 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 to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1120-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-12-24 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flowonix Medical |
| Distribution | US |
Product
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Reason
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.
Identifiers
| code_info | All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10JW4A32 1…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 10A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1120-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.