FDA Device recall Z-1124-2020
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-1124-2020 |
| 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. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
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. |
|---|
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-1124-2020%22
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