Flowonix Medical recalls Prometra Programmable 20mL pumps with firmware 0.26 from 2012 onward due to potential alarm failure during critical valve conditions. Affected units may not alert users to valve 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 Medical is recalling Prometra Programmable 20mL pumps with firmware version 0.26 made from 2012 onward because the pump may not send error alerts or make audible alarms when valve systems go out of tolerance. This could mean users don't know if the pump is malfunctioning during critical situations.
The pump's firmware may fail to send error notifications or emit audible alarms when the valve system goes out of tolerance. This could prevent users from knowing if the pump is malfunctioning during critical conditions.
Patients using the implantable Prometra pump with firmware version 0.26 made from 2012 onward are most at risk. The recall applies to all units with this specific firmware version.
Check for the pump's catalog number 91827 and firmware version 0.26. The device was manufactured from 2012 until the present time and sold with GTIN-14 00810335020XXX.
Look for the firmware version on the pump's label or documentation to confirm it is 0.26.
Reach out to Flowonix Medical for guidance on next steps if the pump has firmware version 0.26.
The pump may not send error notifications or emit audible alarms when the valve system goes out of tolerance, which could prevent users from knowing if the pump is malfunctioning.
Firmware version 0.26 manufactured from 2012 until the present time.
Check for the catalog number 91827 and firmware version 0.26 on the pump's label or documentation.
We’ve drafted a message you can send Flowonix Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1124-2020 — Flowonix Medical Flowonix Medical Hello, I own a Flowonix Medical that is covered by recall Z-1124-2020 from Flowonix Medical. 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.
