[Recalled] Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 — Fluid ingress that can cause a loss of electrical funtion and failure of the Se… | FDA 2023-03-10

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Fresenius Kabi USA, LLC

• Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 — Class I
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25. — Class II
• LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 — Class II
• Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 — Class I
• Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. — Class I
• LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. — Class I

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.