FDA recall Z-1381-2022
Ivenix, Inc. · Class II · device
Product
Ivenix Infusion System (IIS)
Reason for recall
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Distribution
US Nationwide distribution in the states of NJ and WI.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-22
- Report date
- 2022-07-20
- Termination date
- 2024-05-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- North Andover, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1381-2022