Fresenius Kabi recalls Ivenix Infusion System Large Volume Pump LVP-0004 due to mechanical interference causing pump alarms and potential therapy delays or interruptions that could lead to serious harm or death.
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Fresenius Kabi is recalling its Ivenix Infusion System Large Volume Pump model LVP-0004 because it may experience mechanical interference on fluid valve pins, triggering a pump problem alarm. This could delay or interrupt therapy, which might lead to serious harm or death depending on the treatment and how long the interruption lasts.
The device may have mechanical interference on the fluid valve pins, which causes the pump to trigger a 'Pump Problem' alarm. This can delay or interrupt therapy, and if the interruption is prolonged, it could lead to serious harm or death depending on the patient's treatment needs.
Patients using the Ivenix Infusion System Large Volume Pump LVP-0004 for medical therapy are most at risk. This recall affects specific serial numbers listed in the official notice.
Check if your Ivenix Infusion System Large Volume Pump has a serial number listed in the provided list (e.g., 2213800363, 2213800343, etc.). The product was sold with specific serial numbers identified in the recall notice.
If your pump triggers a 'Pump Problem' alarm, stop using it immediately and contact Fresenius Kabi for further instructions.
Reach out to Fresenius Kabi USA, LLC to confirm if your pump is affected and get guidance on next steps.
Yes, the device may cause therapy delays or interruptions that could lead to serious harm or death depending on the treatment and duration of interruption.
Check if your pump's serial number is listed in the provided list (e.g., 2213800363, 2213800343, etc.).
No, but if your pump triggers a 'Pump Problem' alarm, stop using it immediately and contact Fresenius Kabi.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall Z-0549-2024 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall Z-0549-2024 from Fresenius Kabi. 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.
