Recall Z-0362-2019— Fresenius Vial Sa

Name: FDA recall Z-0362-2019
Creator: U.S. Food and Drug Administration
Published: 2017-12-02

Class II · Terminated

Class II FDA medical device recall by Fresenius Vial Sa, initiated 2017-12-02, terminated 2021-02-11. It names one FDA 510(k) clearance: K121613. Product: 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: 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..

Recalling firm: Fresenius Vial Sa
Classification: Class II
Status: Terminated
Initiated: 2017-12-02
Terminated: 2021-02-11
Firm location: Brezins, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K121613 — AGILIA INFUSION SYSTEMFresenius Kabi AG·cleared 2013-05-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.