FDA recall Z-1313-2023

Product

Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004

Reason for recall

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.

Distribution

Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.

Key facts

Status

Ongoing

Initiation date

2023-03-10

Report date

2023-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2023