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