Fresenius Vial Sa: Medical Device Recall in 2018 - (Recall #: Z-0362-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: December 2, 2017

Date Posted: November 7, 2018

Recall Number: Z-0362-2019

Event ID: 81208

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.

Status: Terminated

Product Quantity: 7082 units

Code Information:

Model Catalog Z021135

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated