medical HIGH RISK Updated 2026-06-10

Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Co

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Recalled Product

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

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Hazard / Issue

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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