Flowonix recalls Prometra II Programmable 20mL pumps with firmware 0.26 from 2012 onward due to potential alarm failure. Affected units may not alert users to valve system issues.
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.
Flowonix is recalling its Prometra II Programmable 20mL implantable infusion pumps that have firmware version 0.26. The pumps might not send error notifications or make audible alarms when valve systems go out of tolerance, which could lead to undetected problems.
The pump's firmware may fail to send error codes or produce audible alarms during valve system issues. This could mean users don't know when the pump is malfunctioning, potentially leading to treatment complications.
Patients using the Prometra II pumps with firmware version 0.26 manufactured from 2012 onward are most at risk. This includes individuals receiving medical treatments through these pumps.
Check for the pump model 'Prometra II Programmable 20mL' with catalog number 93827. Affected units have firmware version 0.26 made between 2012 and present.
Look for the firmware version on the pump's label or documentation to confirm it's version 0.26.
Reach out to Flowonix Medical Inc for assistance with the recall process or to get a replacement.
The pump may not send error notifications or emit audible alarms during valve system issues, which could lead to undetected malfunctions.
Firmware version 0.26 manufactured from 2012 until the present time.
Check the pump's label for catalog number 93827 and firmware version 0.26 made between 2012 and present.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1125-2020 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1125-2020 from Flowonix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
