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Fresenius Kabi USA, LLC Recall 93968

Description: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Fresenius Kabi USA, LLC Recall 93968 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1283-2024
Event ID93968
Event DescriptionLVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Product TypeDevices
DistributionUS Nationwide distribution to the states of CA, CO, NJ, WI, UT.
Quantity6 US
Recall ReasonRetroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Device Classification20240320
Device Code InfoUDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Center Classification Date20240311
Recall Initiation Date20230510
Recalling FirmFresenius Kabi USA, LLC
Initial Notification Other
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