FDA-Device2026-01-21Class II
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical, Inc.
Hazard
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
Sold states
Worldwide - US Nationwide distribution.
Affected count
423 units
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
Plum Duo Infusion System, List Number 40002-04-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2026Don't want to check this manually?
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