Flowonix recalls Prometra II 40mL implantable infusion pumps with firmware version 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 Prometra II 40mL implantable infusion pumps with firmware version 0.26 made from 2012 to present. This recall is because the pump might not send error alerts or make audible alarms when valve systems go out of tolerance, which could lead to missed medication adjustments.
The pump's firmware may fail to send error notifications or emit audible alarms during valve system 'out of tolerance' conditions. This means users might not know when the pump is malfunctioning, potentially leading to incorrect medication delivery.
Patients using the Prometra II 40mL pump for medical infusion therapy are affected. Those with pumps manufactured from 2012 onward and firmware version 0.26 are most at risk.
Check if your pump has the catalog number 16827 and serial numbers listed in the recall notice. Units with firmware version 0.26 manufactured from 2012 to present are affected.
Look for serial numbers on the pump: 10GC4A24X, 10GC4A02X, 10GC4A18X, 10GC4A22X, 10GC4A14X, 4MA00044X, 4MA00006X, 10GC4A12X, 10GC4A09X, 10GC4A06X, 10GC4A21X, 4MA00008X, 10GC4A01X, 10GC4A20X, 10GC4A11X, 10GC4A16X, 10GC4A17X, 4MA00045X, 4MA00055X, 10GC4A08X, 4MA00032X, 4MA00031X, 4MA00010X, 4MA00042X.
Reach out to Flowonix Medical Inc for assistance with the recall process.
The Prometra II 40mL pump with catalog number 16827 and firmware version 0.26 manufactured from 2012 to present.
Check if your pump has the serial numbers listed in the recall notice or was manufactured with firmware version 0.26 from 2012 onward.
No, but you should check your pump's serial number and contact Flowonix Medical Inc for guidance.
We’ve drafted a message you can send Flowonix to request your refund or repair — edit it as you like.
Subject: Recall Z-1122-2020 — Flowonix Flowonix Hello, I own a Flowonix that is covered by recall Z-1122-2020 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.
