Brezins, N/A, France
Fresenius Vial Sa recalls
1 recall recorded since 2018, most recently on 2 December 2017. 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
- 2 December 2017
- Terminated
- 11 February 2021
- Reason
- Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusion Pump because it was designed to improve customer experience while preventing common software malfunctions.
- Distribution
- Worldwide distribution - US Nationwide and countries of Canada and China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0362-2019
- Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities enviro
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.