North Andover, MA, United States
Ivenix, Inc. recalls
1 recall recorded since 2018, most recently on 22 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 April 2022
- Terminated
- 20 May 2024
- Reason
- Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
- Distribution
- US Nationwide distribution in the states of NJ and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1381-2022
- Ivenix Infusion System (IIS)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.