FDA-Device2022-07-20Class II

Ivenix Infusion System (IIS)

Ivenix, Inc.
Hazard

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

Sold states
US Nationwide distribution in the states of NJ and WI.
Affected count
1335 devices
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2022

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