FDA-Device2019-10-30Class II
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
ICU Medical Inc
Hazard
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
Sold states
US nationwide distribution, and Canada
Affected count
47,152 devices
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2020Don't want to check this manually?
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