FDA Device Recall Z-1019-2025
Fresenius Kabi USA, LLC · North Andover, MA
Class I — life-threatening Ongoing
Device
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Reason for recall
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Recall record
- Recall number
Z-1019-2025- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
- Recall initiated
- 2025-01-10
- Classified by FDA Center
- 2025-02-04
- FDA published
- 2025-02-12
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- North Andover, MA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.