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Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

  • Volumat MC Agilia Infusion System and Vigilant Drug Library
  • Models
    • Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
    • Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
  • Lot Numbers: All
  • Manufacturing Dates: All
  • Distribution Dates: All
  • Devices Recalled in the U.S.:
    • Volumat MC Agilia – 9,461
    • Vigilant Drug Library – 83
  • Date Initiated by Firm: June 21, 2019

Who May be Affected

  • Health care providers and facilities using a Volumat MC Agilia Infusion System with or without the Vigilant Drug Library
  • Patients receiving infusions with the Volumat MC Agilia Infusion System with or without the Vigilant Drug Library

Learn More

2019-08-15T19:22:46+00:00