Flowonix recalls Prometra Programmable 20mL pumps with firmware version 0.26 from 2012 onward due to potential failure to alert users of 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 Programmable 20mL pumps that were manufactured with firmware version 0.26 from 2012 onward. The pumps may not send error notifications or emit audible alarms when valve systems go out of tolerance, which could lead to undetected problems with medication delivery.
The pump's firmware may not send error codes or produce audible alarms when the valve system goes out of tolerance. This could mean users don't know when the pump is malfunctioning, potentially leading to incorrect medication dosing.
Patients using the Prometra Programmable 20mL pump for medical infusion therapy are affected. Those with pumps manufactured from 2012 with firmware version 0.26 are most at risk.
Check if your pump has a serial number listed in the provided list (e.g., 10JW4A32, 10HW4A29) or was manufactured with firmware version 0.26 between 2012 and the present.
Compare your pump's serial number against the list of affected serial numbers provided in the recall notice.
Reach out to Flowonix Medical Inc for further assistance or to confirm if your pump is affected.
Check if your pump's serial number is in the list provided in the recall notice or if it was manufactured with firmware version 0.26 from 2012 onward.
Contact Flowonix Medical Inc to confirm if your pump is affected and follow their instructions for next steps.
Pumps with firmware version 0.26 manufactured from 2012 onward are affected. Check your pump's serial number against the list provided in the recall notice.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1120-2020 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1120-2020 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.
