Ivenix recalls specific IIS software version 5.0 units with serial numbers starting with 2118200011. Downstream occlusion alarms sometimes immediately follow pump problem alarms, potentially causing treatment interruptions.
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Ivenix is recalling certain infusion systems (IIS) with software version 5.0. These devices may show a downstream occlusion alarm followed by a pump problem alarm, which could interrupt treatment. Affected units have specific serial numbers starting with 2118200011.
The downstream occlusion alarm sometimes triggers immediately after a pump problem alarm. This sequence could cause treatment interruptions or incorrect dosing if the system fails to properly alert the user about the issue.
Patients using Ivenix Infusion Systems (IIS) with software version 5.0 are most at risk. The recall affects specific units with serial numbers starting with 2118200011.
Check your Ivenix Infusion System (IIS) serial number. Affected units have specific serial numbers starting with 2118200011, 2119300411, 2119300414, and other patterns listed in the recall notice.
Look for the serial number on your Ivenix Infusion System (IIS) device. Affected units have specific serial numbers starting with 2118200011, 2119300411, 2119300414, and other patterns listed in the recall notice.
If your device is affected, contact Ivenix directly for instructions on how to proceed with the recall.
Ivenix is recalling specific IIS units with software version 5.0 that may show a downstream occlusion alarm followed by a pump problem alarm, potentially causing treatment interruptions.
Check your device's serial number. Affected units have specific serial numbers starting with 2118200011, 2119300411, 2119300414, and other patterns listed in the recall notice.
Contact Ivenix directly for instructions on how to proceed with the recall. They will provide guidance on whether to stop using the device or take other steps.
We’ve drafted a message you can send Ivenix to request your refund or repair — edit it as you like.
Subject: Recall Z-1381-2022 — Ivenix Ivenix Hello, I own a Ivenix that is covered by recall Z-1381-2022 from Ivenix. 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.
