August 13, 2019

FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious.

The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of Infusion” alarm error and multiple software errors. One death has been reported.

All lots, manufacturing dates, and distribution dates of these items are being recalled.

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