Z-0362-2019 Class II Terminated

Recalled by Fresenius Vial Sa — Brezins, N/A

Recall Details

Product Type
Devices
Report Date
November 7, 2018
Initiation Date
December 2, 2017
Termination Date
February 11, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7082 units

Product Description

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 environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required).

Reason for Recall

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 Pattern

Worldwide distribution - US Nationwide and countries of Canada and China.

Code Information

Model Catalog Z021135