FDA Device Recall Z-1484-2024

Fresenius Kabi USA, LLC · North Andover, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Lot / serial / GTIN: Product LVP-SW-0004; UDI-DI 00811505030122.

Quantity: 17 units

Reason for recall

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

Recall record

Recall number: Z-1484-2024
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: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Recall initiated: 2024-03-07
Classified by FDA Center: 2024-04-11
FDA published: 2024-04-17
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.

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