Recall Z-1283-2024— Fresenius Kabi USA, LLC

Name: FDA recall Z-1283-2024
Creator: U.S. Food and Drug Administration
Published: 2023-05-10

Class II · Completed

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2023-05-10. It names one FDA 510(k) clearance: K183311. Product: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004. Reason: Retroactively 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..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Completed
Initiated: 2023-05-10
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Retroactively 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.