FDA-Device2017-08-23Class II
Plum 360 Infusion System
ICU Medical Inc
Hazard
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Sold states
Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
Affected count
68,559 units
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
Plum 360 Infusion System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3031-2017Don't want to check this manually?
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