Recall Z-2223-2026
- Recall number
- Z-2223-2026
- Event number
- 98929
- Firm
- Fresenius Kabi USA, LLC
- Firm FEI
- 3014732157
- Product code
- FRN
- Status
- Open, Classified
- Initiated
- 2026-05-06
- Posted
- 2026-06-03
- Root cause
- Software design (manufacturing process)
- 510(k) numbers
- K183311, K991437, K062699, K823204, K023083, K893488, K851821, K904048, K904518, K871728, K841018, K832410, K172831, K912914, K910758, K141102, K925091, K010924, K822761, K903787, K841374, K771300, K831897, K013776, K844768, K782034, K934671, K812917, K924865, K111275
Product#
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason for Recall#
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.