Recall Z-2065-2019— Fenwal Inc

Class I FDA medical device recall by Fenwal Inc, initiated 2019-06-24, terminated 2023-03-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigilant Drug Lib Agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the Volumat MC Agilia infusion pumps. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.).. Reason: The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib.

Recalling firm

Fenwal Inc

Classification

Class I

Status

Terminated

Initiated

2019-06-24

Terminated

2023-03-06

Firm location

Lake Zurich, IL, United States

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