Flowonix Medical recalls US Clinical 20mL Programmable Pumps with firmware version 0.26 from 2012 onward due to potential alarm failure. Affected units may not notify errors or emit alarms during 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 Medical is recalling its US Clinical 20mL Programmable Pumps with firmware version 0.26 made from 2012 to present. This recall is due to a possible failure in the pump's alarm system that could prevent it from alerting users to valve system problems.
The pump's firmware may not send error notifications 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 delivery.
Patients using the US Clinical 20mL Programmable Pump for medical infusion therapy are affected. Those with pumps manufactured from 2012 with firmware version 0.26 are most at risk.
Check for serial numbers listed in the recall notice: 10HW4A57, 10AX4A06, 36ES4A15, and other specific serial numbers provided. The pump was manufactured with firmware version 0.26 from 2012 until the present.
Compare your pump's serial number with the list of affected serial numbers provided in the recall notice.
Reach out to Flowonix Medical for further assistance if you have an affected pump.
The pump's firmware may not send error notifications or produce audible alarms during valve system issues, which could lead to undetected malfunctions.
Pumps with firmware version 0.26 manufactured from 2012 to the present are affected.
Check your pump's serial number against the list of affected serial numbers provided in the recall notice.
We’ve drafted a message you can send Flowonix Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1123-2020 — Flowonix Medical Flowonix Medical Hello, I own a Flowonix Medical that is covered by recall Z-1123-2020 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.
